Dual-task Training Using Virtual Reality

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Dual Task Walking (DTW)

Single-task Treadmill Walking (TMW)

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Academic College at Wingate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental-DTW

Control- TMW

Arm Description

The intervention of the experimental group was based on dual-task treadmill walking while using the Virtual Reality (VR) tool.

The intervention of the control group was based on single-task treadmill walking.

Outcomes

Primary Outcome Measures

change in 10-meter walking test across pre, post and follow-up time points.

Change in Timed up and go across pre, post and follow-up time points.

Change in Functional Reach Test across pre, post and follow-up time points.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03577353

First Posted

May 21, 2018

Last Updated

July 3, 2018

Sponsor

Loewenstein Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03577353

Brief Title

Dual-task Training Using Virtual Reality

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 30, 2013 (Actual)

Primary Completion Date

August 18, 2016 (Actual)

Study Completion Date

November 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Loewenstein Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

experimental-DTW

Arm Type

Experimental

Arm Description

The intervention of the experimental group was based on dual-task treadmill walking while using the Virtual Reality (VR) tool.

Arm Title

Control- TMW

Arm Type

Active Comparator

Arm Description

The intervention of the control group was based on single-task treadmill walking.

Intervention Type

Behavioral

Intervention Name(s)

Dual Task Walking (DTW)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Single-task Treadmill Walking (TMW)

Intervention Description

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.

Primary Outcome Measure Information:

Title

change in 10-meter walking test across pre, post and follow-up time points.

Time Frame