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StrokeNCT02491203

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

A study testing Telerehabilitation system in people with Stroke, run by Université de Montréal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Telerehabilitation system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteCanada
Study dates
Sep 2014to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Montreal

    Montreal, Quebec, H3N 1X7

Other trials in Canada

About this study

Official title: Maximizing Post-stroke Upper Limb Rehabilitation Using a Novel Telerehabilitation Interactive Virtual Reality System in the Patient's Home

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.

Read the 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.

Conditions
Stroke
Being tested
Telerehabilitation system
Keywords
Virtual reality, telerehabilitation, Stroke rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation systemOther

    Usual care plus home-based virtual reality telerehabilitation system.

Study groups in NCT02491203
Study groupRoleWhat they receive
Usual careNo interventionAll 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 systemExperimentalParticipants 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.
Receives: Other: Telerehabilitation system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Upper limb motor control at 4 weeks

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

    Measured: baseline and four weeks after intervention

Secondary outcomes (3)

  1. 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

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

  2. Change from Baseline in Upper limb motor control at 4 weeks

    Box and Block test.

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

  3. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2016
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02491203
Sponsor's protocol ID
CRIR-937-0214
Status last verified
Nov 2018
First submitted
13 Jun 2015
Last updated
28 Nov 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19233729

  • 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.

    PubMed 22179539

  • 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.

    PubMed 15947263

  • 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

  • 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.

    PubMed 23319181

  • 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.

  • 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.

    PubMed 36166289

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation system in people with Stroke, run by Université de Montréal at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Upper limb motor control at 4 weeks (time frame: baseline and four weeks after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02491203, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018; AzTrials last refreshed its copy on 31 Oct 2026.

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