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Upper Limb Stroke Rehabilitation Via the VirtualRehab Platform

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise-based games via the VirtualRehab platform
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Virtual Reality, Stroke Rehabilitation, Upper limb, Physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The University of East Anglia Movement and Exercise Physiology Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

The control group will undertake the measurement battery and provide the demographic details.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 24, 2020
Last Updated
August 17, 2020
Sponsor
University of East Anglia
Collaborators
Evolv
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1. Study Identification

Unique Protocol Identification Number
NCT04517812
Brief Title
Upper Limb Stroke Rehabilitation Via the VirtualRehab Platform
Official Title
Consideration-of-concept of the VirtualRehab Platform for Delivery of Upper Limb Rehabilitation at Home for People Late After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia
Collaborators
Evolv

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
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.
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: to assess the acceptability and usability of the VirtualRehab platform for delivery of stroke rehabilitation at home: to find if stroke survivors adhere to 'prescribed' use of the VirtualRehab platform over a 12-week period; 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual Reality, Stroke Rehabilitation, Upper limb, Physical therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Masking Description
masking not considered for this feasibility investigation
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will undertake the measurement battery and provide the demographic details.
Intervention Type
Other
Intervention Name(s)
Exercise-based games via the VirtualRehab platform
Intervention Description
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.
Primary Outcome Measure Information:
Title
Surface Electromyography, change over intervention period
Description
Time to onset for muscle activity during a reaching task
Time Frame
baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)
Title
Change in motor impairment, pre to post
Description
Hand grip force forces (KG) will be made using a Myometer.
Time Frame
baseline 1, baseline 2, post-intervention (3 weeks)
Title
Change in motor impairment, over intervention period
Description
The Motricity Index (scores)
Time Frame
baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)
Title
Change in functional ability, pre to post
Description
The Wolf Motor Function Test (WMFT) scores
Time Frame
baseline 1, baseline 2, post-intervention (3 weeks)
Title
Change in functional ability, over intervention period
Description
iThe Action Reaction Arm Test (ARAT).
Time Frame
baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
The University of East Anglia Movement and Exercise Physiology Lab
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR47TJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data sharing is not indicated for this early phase feasibility study unless requests are received for future systematic reviews

Learn more about this trial

Upper Limb Stroke Rehabilitation Via the VirtualRehab Platform

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