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Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telerehabilitation system
Sponsored by
Université de Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual reality, telerehabilitation, Stroke rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke (does not have to be a first time stroke);
  • Mild to moderate upper limb impairment (score 3-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician);
  • At least 6 months post stroke;
  • No longer receiving rehabilitation services; and (5) living in an area where high speed Internet access is available.

Exclusion Criteria:

  • Being medically unstable;
  • Severe cognitive or communication deficits;
  • Visual impairments;
  • Severe balance deficits limiting sitting safely independently;
  • Shoulder pain;
  • Previous upper limb impairment limiting potential recovery.

Sites / Locations

  • University of Montreal

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Telerehabilitation system

Arm Description

All study participants in the control group will receive a 4-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.

Participants in the experimental group will receive four weeks written home exercise program provided by a clinician, i.e. usual care discharge home program plus virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and the program adapted to ensure it remains at an appropriate level for the patient.

Outcomes

Primary Outcome Measures

Change from Baseline in Upper limb motor control at 4 weeks
as measured using the Fugl-Meyer Assessment-UE (FMA-UE).

Secondary Outcome Measures

Change from Baseline in quality of life at 4 weeks
measured using the Stroke Impact Scale-16, a stroke-specific, self-report, health status measure featuring 16 items capturing daily activities
Change from Baseline in Upper limb motor control at 4 weeks
Box and Block test.
Change from Baseline in Upper limb function at 4 weeks
Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use

Full Information

First Posted
June 13, 2015
Last Updated
November 27, 2018
Sponsor
Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02491203
Brief Title
Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home
Official Title
Maximizing Post-stroke Upper Limb Rehabilitation Using a Novel Telerehabilitation Interactive Virtual Reality System in the Patient's Home
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is a leading cause of death and long-term disability worldwide and its incidence is on the rise. Importantly, loss of arm function occurs in up to 85% of stroke survivors, with a significant long-term impact on activities of daily living, leisure activities and work. The capacity for recovery following a stroke depends on several factors, including the extent of the initial neurological damage, spontaneous recovery and rehabilitation, with possible recovery even years after the stroke. Unfortunately, accessibility of much needed rehabilitation services poststroke often remains limited, both in terms of intensity and duration, as reported in a recent report on post-stroke rehabilitation services in Quebec (Richard, 2013) Recent evidence suggests that homebased telerehabilitation (TR) is a viable approach for upper limb training post-stroke when rehabilitation services are not available. Similarly, the Canadian Best Practice Recommendations for Stroke Care update for 2013 recommends home-based patient monitoring be used when frequent monitoring is needed and face-to-face visits are not available. Hence, The investigators have developed and propose to examine the use of a TR system that allows upper limb rehabilitation with ongoing off-line monitoring, to be used after usual poststroke rehabilitation is completed and services are no longer offered.
Detailed Description
More specifically, the objective of the proposed study is to assess the impact, in terms of motor recovery, function,quality of life, compliance, safety and cost, of a novel, patient-centered home-based tailored TR program using an affordable virtual reality system for upper-limb rehabilitation post-stroke. Such a system, combined with remote off-line monitoring could allow patients to take charge and pursue their rehabilitation beyond current services, maximizing their potential for recovery. A single-blind two-arm randomized clinical trial (RCT) is proposed for this study with participants who have had a stroke randomly allocated to: (1) 4-week training with home-based tele-rehabilitation (TR) system (see intervention below).i.e. treatment group or (2) 4-week written home exercise program provided by a clinician, i.e. exercise control group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Virtual reality, telerehabilitation, Stroke rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
All study participants in the control group will receive a 4-week written home exercise program (e.g. GRASP) , i.e. the usual care discharge home program.
Arm Title
Telerehabilitation system
Arm Type
Experimental
Arm Description
Participants in the experimental group will receive four weeks written home exercise program provided by a clinician, i.e. usual care discharge home program plus virtual reality (VR) and telerehabilitation system. The intensity and choice of game for the home program will be determined by the therapist based on the patient's abilities, interests, motivation and fatigue. The patient's performance for the VR home program will be monitored asynchronously and the program adapted to ensure it remains at an appropriate level for the patient.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation system
Intervention Description
Usual care plus home-based virtual reality telerehabilitation system.
Primary Outcome Measure Information:
Title
Change from Baseline in Upper limb motor control at 4 weeks
Description
as measured using the Fugl-Meyer Assessment-UE (FMA-UE).
Time Frame
baseline and four weeks after intervention
Secondary Outcome Measure Information:
Title
Change from Baseline in quality of life at 4 weeks
Description
measured using the Stroke Impact Scale-16, a stroke-specific, self-report, health status measure featuring 16 items capturing daily activities
Time Frame
At intake into the study ( post-stroke; chronic phase) and four weeks after intervention
Title
Change from Baseline in Upper limb motor control at 4 weeks
Description
Box and Block test.
Time Frame
At intake into the study ( post-stroke; chronic phase) and four weeks after intervention
Title
Change from Baseline in Upper limb function at 4 weeks
Description
Impact on upper extremity use in daily activities will be using the Motor Activity Log, a self-reported measure of upper limb use
Time Frame
At intake into the study ( post-stroke; chronic phase) and four weeks after intervention
Other Pre-specified Outcome Measures:
Title
Economic evaluation at 4 weeks after intervention
Description
Cost-effectiveness analysis (CEA) comparing the intervention with usual care
Time Frame
at 4 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic or hemorrhagic stroke (does not have to be a first time stroke); Mild to moderate upper limb impairment (score 3-6 Chedoke-McMaster arm component or ability to perform VR tasks at least at the lowest setting according to clinician); At least 6 months post stroke; No longer receiving rehabilitation services; and (5) living in an area where high speed Internet access is available. Exclusion Criteria: Being medically unstable; Severe cognitive or communication deficits; Visual impairments; Severe balance deficits limiting sitting safely independently; Shoulder pain; Previous upper limb impairment limiting potential recovery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dahlia Kairy, PhD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3N 1X7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19233729
Citation
Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.
Results Reference
background
PubMed Identifier
22179539
Citation
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available. Erratum In: Circulation. 2012 Jun 5;125(22):e1002.
Results Reference
background
PubMed Identifier
15947263
Citation
Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9.
Results Reference
background
Citation
Richards C. Trajectoires de services de réadaptation post-AVC. Un continuum centré sur la personne: Comité d'experts sur l'offre de services de réadaptation post-AVC;2013
Results Reference
background
PubMed Identifier
23319181
Citation
Langan J, Delave K, Phillips L, Pangilinan P, Brown SH. Home-based telerehabilitation shows improved upper limb function in adults with chronic stroke: a pilot study. J Rehabil Med. 2013 Feb;45(2):217-20. doi: 10.2340/16501977-1115.
Results Reference
background
Citation
Dawson AS KJ MA, Foley N, Teasell R. Chapter 5: Stroke Rehabilitation. In: Lindsay MP GG BM, Phillips S, ed. Canadian Best Practice Recommendations for Stroke Care: Canadian Stroke Best Practices and Standards Working Group; 2013.
Results Reference
background
PubMed Identifier
36166289
Citation
Hernandez A, Bubyr L, Archambault PS, Higgins J, Levin MF, Kairy D. Virtual Reality-Based Rehabilitation as a Feasible and Engaging Tool for the Management of Chronic Poststroke Upper-Extremity Function Recovery: Randomized Controlled Trial. JMIR Serious Games. 2022 Sep 27;10(3):e37506. doi: 10.2196/37506.
Results Reference
derived

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Post-stroke Upper Limb Rehabilitation Using Telerehabilitation Interactive Virtual Reality System in the Patient's Home

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