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CompletedNCT02916797Updated Mar 12, 2019

Stepping Training Using Feedback in Stroke

An interventional study of Stepping training with feedback in Cerebrovascular Accident, sponsored by Khon Kaen University. Completed. Open to participants aged 45 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-03-12.

Sponsored by Khon Kaen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2016, registered Sep 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
45 Years to 74 Years
Sex
All
01

Study summary

  • Are there differences in immediate effects of stepping training with and without the use of visually weight-taking machine (VWTM) on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke?
  • Are there differences of 4-week stepping training with and without the use of VWTM on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke?
Read the detailed description
  • To compare immediate effects of stepping training with or without the use of VWTM on variables relating to well-controlled walking and walking symmetry in ambulatory patients with stroke.
  • To compare effects of 4-week stepping training with or without the use of VWTM on variables relating to well-controlled walking and walking symmetry in patients with stroke.
02

Conditions studied

  • Cerebrovascular Accident

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Keywords

  • Feedback
  • Physical Therapy
03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's enrollment of 36 is below the median of 50 across 5,370 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 160 studies on the registry; 24 are open to participants now.

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

04

Who can participate

Ages eligible
45 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects are independent ambulatory patients with first stroke episode with the age at least 45-74 years old,
  • subacute (post-stroke time \< 6 months) or chronic (post-stroke time ≥ 6 months) stroke
  • Independent walking at least 10 meters with or without a walking device
  • Able to follow verbal command used in this study

Exclusion criteria

Exclusion Criteria:

  • The subjects who have other medical conditions that might affect participation in the study such as uncontrolled underlying diseases (i.e. hypertension, heart disease, thyroid, etc.), deformity in the lower extremities, pain more than 5 out of 10 on a visual analog scale, legally blind or had a history of visual deficits that were unable to be corrected by glasses or contact lens, have a color blindness and inability to communicate or follow the commands used in this study
05

Study design

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

Study arms

  • Experimental
    Stepping training with feedback

    Subjects stand in a step standing position with placing the affected leg on the load cells of the VWTM and the non-affected leg slightly backward outside the load cells, look forward to light bars of the displayed section which will be set at their eye level. Then subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can. Subjects repetitively practice the task for 30 minutes with a period of sufficient rest as required.

    Other: Stepping training with feedback

  • No intervention
    Stepping training without feedback

    Subjects will be trained and instructed the same as the experimental group but without using the displayed section, for approximately 30 minutes/day (excluding rest periods), 5 days/week, for 4 week. Then, every subject will be trained to walk overground with or without a walking device for 10 minutes in order to promote transferability of the part-task practice to the whole/target task. Subjects still receive routine treatments from other rehabilitation professionals as needed during participation in the study.

Interventions

  • OtherStepping training with feedback

    Stepping training with the use of external feedback. The subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can.

06

What researchers measure

Primary outcomes

  1. 10MWT

    Walking speed

    Time frame: 4 weeks

Secondary outcomes

  1. 6MWT

    Walking endurance

    Time frame: 4 weeks

  2. TUGT

    Balance and walking ability

    Time frame: 4 weeks

  3. Lower limb support ability

    % of bosy-weight on single leg during stepping

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02916797
Lead sponsor
Khon Kaen University
Responsible party
Sugalya Amatachaya (Assoc. Prof. Dr., Khon Kaen University) — Principal investigator
First posted
Sep 27, 2016
Start date
Apr 10, 2016
Primary completion
Feb 28, 2018
Completion
Feb 28, 2018
Last update
Mar 12, 2019

Study contacts

Sugalya Amatachay, Ph.D.
principal investigator · School of Physical Therapy,Faculty of Associated Medical Sciences, Khon Kaen University, Thailand

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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