Dual-task Training Using Virtual Reality

Stroke Clinical Trial

Official title:

Dual-task Training Using Virtual Reality: Influence on Walking and Balance in Post Stroke Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03577353
• Other study ID #: 0001-13-LOE
• Status: Completed
• Phase: N/A
• Start date: October 30, 2013
• Est. completion date: November 26, 2017

Study information

• Verified date: April 2018
• Source: Loewenstein Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to investigate the feasibility of using a virtual reality- based dual task training of upper extremity tracking while treadmill-walking, to improve walking and balance performance in post stroke survivors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 26, 2017
• Est. primary completion date: August 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• With hemiplegia after a stroke for at least a year since the incident.

• Range age 40-80.

• Without medication or with stabilized medication.

• Use ankle-foot orthosis or no splint at all.

Exclusion Criteria:

• Severe cardiac problems

• A score less than 25 in the Mini-Mental test.

• Fractures or severe orthopedic limitations that do not allow for training, and which have occurred over the last six months.

• More than three falls in the past year before participating in the study

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Dual Task Walking (DTW)
Each training session began with 8 min of general warm-up and 2 min walk around the gym. Then, for safety reasons, the participants were attached to a harness. The participants began walking slowly on the treadmill for 3 min. In the following phases the participants walked at the same speed, while training with 3 VR games. Each session lasted 3 min, and 3 min of single walking was performed between VR sessions. After the final VR session, 2 min of single-task walking was performed in order to allow for recovery. The time walked in each trial from the starting point to the destination was kept constant at 20 min.
• Single-task Treadmill Walking (TMW)
this intervention, participants performed 8 min of general warm-up and 2 min walk around the gym, and then continued to walk for another 20 min on the treadmill at a speed that was equivalent to the intensity of 60%-70% of their heart rate reserve.

Locations

Country	Name	City	State
Israel	The Academic College at Wingate	Netanya

Sponsors (1)

Lead Sponsor	Collaborator
Loewenstein Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in 10-meter walking test across pre, post and follow-up time points.		Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Primary	Change in Timed up and go across pre, post and follow-up time points.		Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Primary	Change in Functional Reach Test across pre, post and follow-up time points.		Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Primary	Change in Activities-specific Balance Confidence (ABC) Scale	Activities-specific Balance Confidence (ABC) Scale is a 16-item questionnaire/survey. Each item is rated from 0% (no confidence) to 100% (complete confidence). Elderly respondents are asked to rate their confidence that they will lose their balance or become unsteady in the course of daily activities. ABC is an 11-point scale and ratings should consist of whole numbers (0-100) for each item. Participants should indicate their level of confidence in doing an activity without losing balance or becoming unsteady by choosing one of the percentage points on the scale from 0%-100%. Total the ratings (possible range = 0 to 1600) and divide by 16 to get each subject's ABC score. Scores lower than 50 indicate a low level of functioning, scores above 50 but below 80 indicate a medium level, and those over 80 indicate a high level of functioning.	Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention
Primary	Change in The Berg Balance Scale (BBS) across pre, post and follow-up time points.	14-item scale designed to measure balance of the older adult in a clinical setting. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function.Total Score = 56. 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk.	Pre-intervention time: one week before the intervention period (4 week).Post intervention time:immediately after the intervention. Follow-up time: 4 weeks after intervention