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Completed

NCT Number: NCT03577353

Dual-task Training Using Virtual Reality

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

Completed

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Academic College at Wingate

Netanya, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  4. Change in Activities-specific Balance Confidence (ABC) Scale

    Time frame: 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

    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.

  5. Change in The Berg Balance Scale (BBS) across pre, post and follow-up time points.

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Loewenstein Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 5, 2018
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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