Upper Limb Stroke Rehabilitation Via the VirtualRehab Platform

August 17, 2020 updated by: University of East Anglia

Consideration-of-concept of the VirtualRehab Platform for Delivery of Upper Limb Rehabilitation at Home for People Late After Stroke

This study will deliver a 12-week exercise-based upper limb virtual reality, non-immersive, rehabilitation programme for stroke survivors. The aims are to:1. to assess the acceptability and usability of the VirtualRehab platform for delivery of stroke rehabilitation at home:

2. to find if stroke survivors adhere to 'prescribed' use of the VirtualRehab platform over a 12-week period; 3. to assess the viability of using randomised length of baselines and repeated measures during the intervention period to inform subsequent study to find the optimum therapeutic dose 4. to estimate how a 12-week period of using the VirtualRehab platform could change motor impairment and functional capacity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background and objectives:

This study is driven by the hypothesis that provision of task-orientated training via a non-immersive virtual reality platform enhances upper limb motor and neural function more than current routine physical therapy for people with stroke. Before this hypothesis can be tested in a randomised controlled clinical trial. If evidence of concept is found, then the next step is identification of the optimum therapeutic dose of exercised-based therapy delivered via the Virtualrehab Platform as a precursor to a clinical efficacy trial. The specific objectives of the study reported here were:

  1. to assess the acceptability and usability of the VirtualRehab platform for delivery of stroke rehabilitation at home:
  2. to find if stroke survivors adhere to 'prescribed' use of the VirtualRehab platform over a 12-week period;
  3. to assess the viability of using randomised length of baselines and repeated measures during the intervention period to inform subsequent study to find the optimum therapeutic dose
  4. to estimate how a 12-week period of

Design:

A series of replicated single case studies with an AB design (2.1). During the A, control, phase participants will not receive the experimental intervention. Participants will receive the experimental intervention during the B phase. At the beginning of the control phase, participants will complete the measurement battery. These will be the baseline-one measures. The measurement battery will be repeated at the end of the baseline phase (baseline-two) and at the end of the intervention phase (outcome). Progress measures will be made at the end of every week of the intervention (B) phase.

Both sets of baselines and the outcome measures will be taken in the Movement and Exercise Laboratory (MovExLab) at the University of East Anglia (UEA). Progress measures will be made in participants' homes. The control phase will last for a randomised period of between one and four weeks. The time period for the control phase will be decided for each participant by a randomised sequence generated before the study begins, by a researcher independent of the research team for this study. The intervention phase will last for 12 weeks. During the intervention phase, each participant will undertake weekly progress measures in their home. These will be administered by the researchers prescribing and monitoring training. At the end of the control and the intervention phase, all participants will participate in a 1:1 semi-structured interview with the researcher.

A group of adults without any reported neurological damage undertook the measurement battery to provide reference values. The measurement battery and progress measures are described below.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR47TJ
        • The University of East Anglia Movement and Exercise Physiology Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Stroke participants:

Inclusion criteria:

(A) Adults (18+); (B) At least six months after stroke; (C) A score of at least 19/33 on the Motricity Index elbow flexion and shoulder abduction section but unable to complete the Nine Hole Peg Test (9HPT) in 50 seconds or less with their more paretic upper limb.

(D) Able to use the more paretic upper limb to drink from a cup, prior to onset of the index stroke.

(E) Have an appropriate space in their home for the VirtualRehab platform's sensors to detect movement.

(F) Able to play the VirtualRehab 'boxing game' with their less paretic upper limb to indicate the ability to follow instructions relevant to the non- immersive VirtualRehab platform; (G) Fit to participate safely within this exercise-based training programme as assessed by a resting heart rate of 90 beats per minute or less and a systolic blood pressure of 140mmHg or less.

Neurologically-Intact People

Inclusion criteria

(A) No reported clinical diagnosis of stroke, epilepsy or other neurological pathology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The intervention group will carry out a 12-week exercise-based intervention delivered via the VirtualRehab platform. The exercise-games have been designed from conventional physiotherapy exercises for stroke rehabilitation. A personalised training programme will be created for individual participants by a qualified physiotherapist member of the research team. Each participant will be asked to undertake their set exercise-based training programme for one hour a day, six days a week for 12 weeks.
Other: Exercise-based games via the VirtualRehab platform
A 12-week exercise-based home rehabilitation intervention delivered via the VirtualRehab platform. A personalised exercise-based rehabilitation plan will be created for each participant.
No Intervention: Control group
The control group will undertake the measurement battery and provide the demographic details.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface Electromyography, change over intervention period
Time Frame: baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)
Time to onset for muscle activity during a reaching task
baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)
Change in motor impairment, pre to post
Time Frame: baseline 1, baseline 2, post-intervention (3 weeks)
Hand grip force forces (KG) will be made using a Myometer.
baseline 1, baseline 2, post-intervention (3 weeks)
Change in motor impairment, over intervention period
Time Frame: baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)
The Motricity Index (scores)
baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)
Change in functional ability, pre to post
Time Frame: baseline 1, baseline 2, post-intervention (3 weeks)
The Wolf Motor Function Test (WMFT) scores
baseline 1, baseline 2, post-intervention (3 weeks)
Change in functional ability, over intervention period
Time Frame: baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)
iThe Action Reaction Arm Test (ARAT).
baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Collaborators

Evolv

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

August 17, 2020

First Posted (Actual)

August 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 233548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data sharing is not indicated for this early phase feasibility study unless requests are received for future systematic reviews

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Exercise-based games via the VirtualRehab platform

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe