- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916797
Stepping Training Using Feedback in Stroke
March 8, 2019 updated by: Sugalya Amatachaya, Khon Kaen University
Effects of Stepping Training With and Without the Use of Visually Weight-taking Machine (VWTM) on Walking and Balance Ability in Patients With Stroke
- 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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 74 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
10MWT
Time Frame: 4 weeks
|
Walking speed
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6MWT
Time Frame: 4 weeks
|
Walking endurance
|
4 weeks
|
|
TUGT
Time Frame: 4 weeks
|
Balance and walking ability
|
4 weeks
|
|
Lower limb support ability
Time Frame: 4 weeks
|
% of bosy-weight on single leg during stepping
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sugalya Amatachay, Ph.D., School of Physical Therapy,Faculty of Associated Medical Sciences, Khon Kaen University, Thailand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 10, 2016
Primary Completion (ACTUAL)
February 28, 2018
Study Completion (ACTUAL)
February 28, 2018
Study Registration Dates
First Submitted
September 22, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (ESTIMATE)
September 27, 2016
Study Record Updates
Last Update Posted (ACTUAL)
March 12, 2019
Last Update Submitted That Met QC Criteria
March 8, 2019
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHD56I0044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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