CClinicalTrials.gg
TerminatedNCT02774603ALTUpdated Oct 9, 2018

Aquatic vs. Land Locomotor Training Overground Locomotor Training in Improving Ambulatory Function and Health-Related Quality of Life

An interventional study of Aquatic Locomotor Training and Land Locomotor Training in Spinal Cord Injury, sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to lack of funding the study was terminated early
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this study is to define and evaluate the efficacy of Aquatic Locomotor Training (ALT) compared to overground Locomotor Training in improving ambulatory function and health-related quality of life. The investigators hypothesize, that Aquatic Locomotor Training is capable of producing outcomes that are as good as, or better than, overground Locomotor Training.

Aquatic Locomotor Training may be another tool for therapists to utilize for clinical improvements in function and gait for the Spinal Cord Injury (SCI) population.

To determine the efficacy of Aquatic Locomotor Training on improving rehabilitation outcomes among patients with incomplete traumatic cervical Spinal Cord Injury by assessing these parameters:

  1. Walking speed and endurance
  2. Functional balance and fall risk
  3. HRQoL

To describe the feasibility of conducting Aquatic Locomotor Training as an Locomotor Training modality for the rehabilitation of patients with incomplete traumatic cervical Spinal Cord Injury.

02

Conditions studied

  • Spinal Cord Injury
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 2 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc. is the lead sponsor of 76 studies on the registry; 19 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 18-65 years
  2. Cervical level (C1-C7) SCI of traumatic origin
  3. Motor incomplete SCI (ASIA Impairment Scale C or D)
  4. Chronic SCI, >12 months
  5. Age between 18 to 65 years
  6. Functional Status

i. Overground ambulator (able to walk at least 10 m with or without an assistive device)

ii. Able to demonstrate active movement at/or below L2 myotome

iii. Able to demonstrate adequate head control

  1. Voluntarily extend head while positioned in harness

iv. Tolerance to activity

  1. Participant able to tolerate up to 1 hour of standing without experiencing symptoms of orthostatic hypotension

g. Range of motion

i. PROM values for ankle dorsiflexion

  1. Neutral positioning, 0○

ii. PROM values for knee extension

  1. Up to -10○

iii. PROM values for hip extension

  1. Neutral positioning, 0○

h. Height

i. Participant with minimum height of 48"

i. Weight

i. Participant with minimum weight of (to be determined based on therapist's clinical judgment)

ii. Participant with maximum weight of 300 lb

j. Participants are able to comply with procedures and follow up

k. Participants are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues

l. Participants are legally able to make their own health care decisions

Exclusion criteria

Exclusion Criteria:

a. Medical Complications i. Fracture

  1. Participant with presence of unhealed fracture ii. Physician hold for medical reasons that the Principle Investigator will judge and decide on a case by case basis as a potential safety threat to the participant
  1. Wounds a. Allowed if physician cleared i. Excluded wounds likely to be present in areas enclosed with harness, present in areas that require access for facilitation, present in areas of direct weight bearing during LT session b. Wounds allowed must be fully covered with gauze then opsite (waterproof bandage) before Aquatic Locomotor Training
  2. Comorbidities a. E.g. poorly controlled diabetes, uncontrolled seizures, etc.
  3. Orthostatic hypotension

    a. Participant demonstrates symptomatic orthostatic hypotension that limits activity

  4. Uncontrolled autonomic dysreflexia symptoms a. Episode of uncontrolled autonomic dysreflexia symptoms within the past 1 month iii. Diarrhea iv. Mechanical ventilation v. Pacemakers vi. Central lines vii. Women who are pregnant, confirmed by a urine pregnancy test that will be done on all menstruating, or non-menopausal women viii. History of neurological disease ix. Non English speaking participants will not be targeted b. Currently undergoing, or have received Aquatic Locomotor Training or overground Locomotor Training within four weeks of the study start date (see above in 4d for further details)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
2 participants (actual)

Study arms

  • Active comparator
    Aquatic Locomotor Training

    Aquatic Locomotor Training is a Locomotor Training technique utilizing an underwater treadmill to help increase a patient's independence and function. Aquatic Locomotor Training may require up to three people to obtain desirable gait kinematics: one at each of the patient's legs, and one at the patient's pelvis; however, typically with ambulatory patients, only one therapist is utilized. Therapists are highly trained, using their legs and feet to provide properly timed underwater cues throughout the gait cycle.

    Other: Aquatic Locomotor Training

  • Active comparator
    Land Locomotor Training

    Locomotor Training encompasses a variety of interventions ranging from BWSTT to overground gait training to robotic-assisted walk training. Overground Locomotor Training, depending upon the technique used, can require up to four people to complete the intervention (one at each participant's leg, one at the participant's trunk and/or pelvis, and one monitoring the computer and/or treadmill).

    Other: Land Locomotor Training

Interventions

  • OtherAquatic Locomotor Training
  • OtherLand Locomotor Training
06

What researchers measure

Primary outcomes

  1. Change from Baseline 10 meter Walk Test at 4 months

    Time frame: up to 16 weeks

Secondary outcomes

  1. 6 Minute Walk Test

    Time frame: up to 16 weeks

  2. Berg Balance Scale

    Time frame: up to 16 weeks

  3. Health Survey on the Short Form 36

    Time frame: up to 16 weeks

  4. Quality of Life on the SCI QL-23 scale

    Time frame: up to 16 weeks

07

Study locations

1 site
  • Cristina Sadowsky, M.D.
    Baltimore, Maryland 21205, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02774603
Lead sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Responsible party
Cristina Sadowsky, M.D. (Assistant Professor, Director, Physician, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.) — Principal investigator
First posted
May 17, 2016
Start date
Jun 2015
Primary completion
Mar 2018
Completion
Mar 2018
Last update
Oct 9, 2018

Study contacts

Cristina Sadowsky, M.D.
principal investigator · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion