CClinicalTrials.gg
CompletedNCT03548090Updated Oct 1, 2021

The Effects of Plantar Flexion Training in People With Chronic Stroke

An interventional study of Skateboard exercise at an incline angle of 0 degrees and 50% body weight and Skateboard exercise at an incline angle of 5 degrees and 50% body weight in Stroke and Hemiplegic Gait, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-01.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors.

The aim of the first phase is to determine if there are differences between standing on different levels of inclination on plantar flexion activation during forward movement of the contralateral LE in adults with chronic with stroke.

The aim of second phase is to determine if there are differences between different percentages of weight bearing on the paretic LE on plantar flexion activation during forward movement of the contralateral LE in adults with chronic stroke.

The aim of the third phase is to determine if there are differences between a 4-week plantar flexion training intervention and conventional physical therapy.

Read the detailed description

Description of Arms:

This study has three phases. The first phase is performed in a cross-over fashion. Participants will stand on two different incline angles on the paretic LE and simultaneously move a small skateboard forward with the non-paretic LE. The testing order for the two different incline angles will be randomized, and all participants will be required to complete both incline angle conditions within a single test session.

The second phase will also be performed in a cross-over fashion. Participants will stand with three different percentages of body weight on their paretic LE while moving the skateboard forward with the non-paretic LE. The testing order for the three body weight percentages will be randomized. All participants will be required to complete all three body weight conditions within a single test session.

In the third phase, participants will be randomized to either a control 4-week exercise intervention (conventional physical therapy) or a 4-week experimental exercise intervention (plantar flexion training). Both the control and exerimental arms will complete over-ground multi-directional gait training and home exercise.

02

Conditions studied

  • Stroke
  • Hemiplegic Gait

Keywords

  • stroke rehabilitation
  • walking limitations
  • gait rehabilitation
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 15 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Must be able to perform five times sit to stand test without the use of upper extremities
  • Must have 10 degrees of passive ankle dorsiflexion measured in standing
  • Must be able to walk with supervision level assistance with no assistive device

Exclusion criteria

Exclusion criteria:

  • Currently receiving physical therapy
  • History of orthopedic ankle instability
  • Lacking knee extension to neutral
  • Unable to understand English
  • Unable to follow multi-step commands
  • History of orthopedic pathology that prevents completion of experimental condition
  • Pain with weight bearing on paretic LE
  • Received Botox to the plantar flexors within the last three months or phenol injections within the last six months
  • Walk with a longer nonparetic step length than paretic step length
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    1

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    2

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    3

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    4

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    5

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    6

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    7

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    8

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    9

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    10

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    11

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    12

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Control 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    13

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    14

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    15

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    16

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    17

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    18

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    19

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    20

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    21

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    22

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    23

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

  • Experimental
    24

    Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention)

    Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight · Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight · Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight · Other: Experimental 4-week exercise intervention · Other: Over-ground multi-directional gait training · Other: Home exercise

Interventions

  • OtherSkateboard exercise at an incline angle of 0 degrees and 50% body weight

    Participants will stand on a specified incline angle (0 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.

  • OtherSkateboard exercise at an incline angle of 5 degrees and 50% body weight

    Participants will stand on a specified incline angle (5 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.

  • OtherSkateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight

    Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (75%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.

  • OtherSkateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight

    Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (90%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.

  • OtherControl 4-week exercise intervention

    This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The control group will perform three sets of ten repetitions of the following 4 exercises, for a total of 120 repetitions: 1) standing hip abduction against green theraband resistance with upper extremity support, 2) sit to stands from chair with no upper extremity support, 3) bilateral calf raises with upper extremity support, and 4) right and left weight shifting exercises using a wobble board with upper extremity support available if needed.

    Also known as: conventional physical therapy

  • OtherExperimental 4-week exercise intervention

    This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The experimental group will perform the skateboard exercise with the optimal parameters established during studies 1 and 2 (that is, an incline angle of either 0 or 5 degrees and a body weight percentage of 50%, 75%, or 90%)--the forward and backward speed of the skateboard will be cued with a metronome that will set at a beats per minute that matches the foot strike cadence of someone walking at 0.7 m/s, and the magnitude of forward excursion of the skateboard will be individualized to the participant based on GAITRite® data (that is, step length of the non-paretic LE).

    Also known as: Plantar flexion training

  • OtherOver-ground multi-directional gait training

    In the over-ground multi-directional gait protocol, the participant will walk 750 steps forward, 50 steps backward, and 200 side steps over level surfaces. The over ground gait training will focus on equalizing step length while performing multi-directional gait training.

  • OtherHome exercise

    Home exercise consists of three sets of ten repetitions of the following three exercises to be performed on non-therapy days over the four weeks of phase 3: 1) sit to stands from chair with no upper extremity support, 2) bilateral calf raises with hand support, and 3) resisted side stepping to the non-paretic side using a green theraband with upper extremity support.

06

What researchers measure

Primary outcomes

  1. Step length asymmetry ratio as assessed by the GAITRite®

    The step length asymmetry ratio will be calculated by dividing the paretic step length by non-paretic step lengths. The magnitude of the ratio indicates the nature of the asymmetry, with symmetrical gait defined as step length ratio of 0.9-1.1, and asymmetrical gait where the non-paretic step lengths are longer than the paretic step lengths with any step length ratio greater than 1.1.

    Time frame: baseline, 6 weeks (relative to the phase 3 intervention)

  2. Muscle activity of the medial gastrocnemius as assessed by surface EMG

    Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).

    Time frame: on the 1 day of the phase 1 intervention

  3. Muscle activity of the soleus as assessed by surface EMG

    Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).

    Time frame: on the 1 day of the phase 1 intervention

  4. Plantar flexion torque as assessed by isokinetic dynamometry

    Peak plantar flexion torque will be acquired using an isokinetic dynamometer(Biodex Medical Systems, Shirely, New York, USA). Calibration of the Biodex® will be performed prior to the assessment of each individual. For each participant, the plantar flexors will be warmed-up on a LE ergometer for 10 minutes prior to testing. The participant will be fully secured to prevent compensatory behaviors from trunk or hips that may influence results. A pre-speed warm up on the Biodex of three submaximal repetitions and one maximal repetition will be conducted prior to testing so the participant understands what these repetitions feel like. The angular velocity will be set a 60°/second, five repetitions will be performed, and the peak torque of the plantar flexors will be collected.

    Time frame: baseline, 6 weeks (relative to the phase 3 intervention)

  5. Muscle activity of the medial gastrocnemius as assessed by surface EMG

    Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).

    Time frame: on the 1 day of the phase 2 intervention

  6. Muscle activity of the soleus as assessed by surface EMG

    Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).

    Time frame: on the 1 day of the phase 2 intervention

Secondary outcomes

  1. Gait speed as assessed by the GAITRite®

    Self-selected gait speed will be acquired using the GAITRite®.

    Time frame: baseline, 6 weeks (relative to the phase 3 intervention)

  2. Muscle activity of the medial gastrocnemius as assessed by surface EMG

    Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).

    Time frame: baseline, 6 weeks (relative to the phase 3 intervention)

  3. Muscle activity of the soleus as assessed by surface EMG

    Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).

    Time frame: baseline, 6 weeks (relative to the phase 3 intervention)

  4. Quality of life as assessed by the Stroke Impact Scale

    The physical domain of the Stroke Impact Scale will used to determine quality of life. The Stroke Impact Scale is a self-report measure designed to capture eight domains of health status. The physical domain has nine items that are rated using a 5 point Likert scale in terms of how difficult certain physical tasks are. The domains are scored separately using a transformed scale formula: \[(raw score - lowest possible raw score) / highest possible raw score\] x 100. A composite score will be assessed.

    Time frame: baseline, 6 weeks (relative to the phase 3 intervention)

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03548090
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
Texas Woman's University
Responsible party
Daniel Wingard (Physical therapist, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Jun 7, 2018
Start date
Oct 1, 2018
Primary completion
Jul 1, 2021
Completion
Jul 1, 2021
Last update
Oct 1, 2021

Study contacts

Daniel P Wingard, DPT
principal investigator · The University of Texas Health Science Center, Houston

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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