Overview

This trial is active, not recruiting.

Condition cerebrovascular accident
Treatment stepping training with feedback
Sponsor Khon Kaen University
Start date October 2015
End date October 2016
Trial size 19 participants
Trial identifier NCT02916797, PHD56I0044

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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 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.
(No Intervention)
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.

Primary Outcomes

Measure
10MWT
time frame: 4 weeks

Secondary Outcomes

Measure
6MWT
time frame: 4 weeks
TUGT
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 45 years up to 74 years old.

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

Additional Information

Official title Effects of Stepping Training With and Without the Use of Visually Weight-taking Machine (VWTM) on Walking and Balance Ability in Patients With Stroke
Principal investigator Sugalya Amatachaya, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Khon Kaen University.