Dual-task Training Using Virtual Reality

NCT03577353 | Completed

• 1 other identifier: 0001-13-LOE
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

experimental-DTW

EXPERIMENTAL

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

Behavioral: Dual Task Walking (DTW)

Control- TMW

ACTIVE COMPARATOR

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

Behavioral: Single-task Treadmill Walking (TMW)

Interventions

Dual Task Walking (DTW) BEHAVIORAL

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.

experimental-DTW

Single-task Treadmill Walking (TMW) BEHAVIORAL

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.

Control- TMW

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loewenstein Hospital: lead

Study Sites (1)

The Academic College at Wingate

Netanya, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yeshayahu Hutzler, Ph.D.

  Graduate School Academic College at Wingate

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: July 5, 2018
• Study Start: October 30, 2013
• Primary Completion: August 18, 2016
• Study Completion: November 26, 2017
• Last Updated: July 5, 2018

Record last verified: 2018-04

Locations

IL (1)