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

NCT02491203 | Completed

• 1 other identifier: CRIR-937-0214
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Virtual reality; telerehabilitation; Stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Upper limb motor control at 4 weeks

  as measured using the Fugl-Meyer Assessment-UE (FMA-UE).

  baseline and four weeks after intervention

Secondary Outcomes (3)

• Change from Baseline in quality of life at 4 weeks

  At intake into the study ( post-stroke; chronic phase) and four weeks after intervention

• Change from Baseline in Upper limb motor control at 4 weeks

  At intake into the study ( post-stroke; chronic phase) and four weeks after intervention

• Change from Baseline in Upper limb function at 4 weeks

  At intake into the study ( post-stroke; chronic phase) and four weeks after intervention

Other Outcomes (1)

• Economic evaluation at 4 weeks after intervention

  at 4 weeks after intervention

Study Arms (2)

Usual care

NO INTERVENTION

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.

Telerehabilitation system

EXPERIMENTAL

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.

Other: Telerehabilitation system

Interventions

Telerehabilitation system OTHER

Usual care plus home-based virtual reality telerehabilitation system.

Telerehabilitation system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

University of Montreal

Montreal, Quebec, H3N 1X7, Canada

Location

Related Publications (7)

• 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.

  PMID: 19233729 BACKGROUND

• 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.

  PMID: 22179539 BACKGROUND

• 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.

  PMID: 15947263 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23319181 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 36166289 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Dahlia Kairy, PhD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2015
• First Posted: July 7, 2015
• Study Start: September 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: January 1, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11

Locations

CA (1)