Upper Limb Stroke Rehabilitation Via the VirtualRehab Platform

NCT04517812 | Completed

• 1 other identifier: 233548
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Virtual Reality; Stroke Rehabilitation; Upper limb; Physical therapy

Outcome Measures

Primary Outcomes (5)

• Surface Electromyography, change over intervention period

  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

  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

  The Motricity Index (scores)

  baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)

• Change in functional ability, pre to post

  The Wolf Motor Function Test (WMFT) scores

  baseline 1, baseline 2, post-intervention (3 weeks)

• Change in functional ability, over intervention period

  iThe Action Reaction Arm Test (ARAT).

  baseline 1, baseline 2, during intervention, post-intervention (up to 15 weeks)

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Exercise-based games via the VirtualRehab platform OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of East Anglia: lead
• Evolv: collaborator

Study Sites (1)

The University of East Anglia Movement and Exercise Physiology Lab

Norwich, Norfolk, NR47TJ, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: masking not considered for this feasibility investigation
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: August 18, 2020
• Study Start: July 18, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)