The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke

NCT03759145 | Completed

• 1 other identifier: CRIR-795-0113
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke is a leading cause of death and disability worldwide.Hemiplegia, weakness of one side of the body, is a common consequence of stroke that can lead to significant functional impairments. Loss of arm function occurs in up to 85% of stroke survivors. The impact of arm-related limitations on activities of daily living, leisure activities or work is significant as the arm plays a central role in a person's life from the ability to perform basic activities of daily life to carrying out family and social roles. Guidelines indicate that rehabilitation can improve upper extremity (UE) motor control and functional status post stroke. Virtual reality (VR) and computer games are recent technologies that, as they become more accessible and affordable,are increasingly being used in rehabilitation to allow patients to engage in repetitive practice of specific tasks. A number of published reviews and meta-analyses have examined the use of VR and video games for post-stroke rehabilitation, focusing on or including UE rehabilitation. The authors agree that there is limited but promising findings that VR and video-games, when combined with traditional rehabilitation, have a positive impact on recovery post-stroke.

Conditions

Stroke

Keywords

virtual reality; exergame; stroke rehabilitation

Outcome Measures

Primary Outcomes (11)

• number of sessions (feasibility)

  number of sessions the participant used the system during the study period

  4 week period

• duration of sessions

  the average duration of sessions (minutes)

  4 week period (ongoing)

• time spent by therapist assisting the participant

  time during the sessions that the therapist spent assisting the participant (minutes)

  4 week period (ongoing)

• time spent on each exergame

  the time spent on each exergame (minutes)

  4 week period (ongoing)

• adverse event (counts)

  occurrence of adverse events such as falls, motion sickness, dizziness and headaches

  4 week period (ongoing)

• adverse event (borg exertion scale, self-reported scale 6-20, (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)

  exertion after playing the exergame reported using the Borg Exertion Scale

  4 week period (ongoing)

• adverse event (pain self reported on visual analog scale 0-10)

  pain after playing the exergame reported using visual analog scale 0-10, 0 is no pain, 10 is the worse pain imaginable.

  4 week period (ongoing)

• Stroke-specific measure of quality of life - Stroke Impact Scale

  Stroke Impact Scale is a questionnaire of the impact that the stroke is having on function, mood, emotional status, total score 0-100, with with higher scores indicating better self-reported health.

  4 week period (per-post)

• upper limb function assessed using the Motor Activity Log

  The Motor Activity Log is a questionnaire that the participant completes reporting how much the impaired upper limb is used for various daily tasks, each task is scored from 0-5 (ordinal scale, 0=do not use arm - 6=use as much as before), total score is mean of the scores.

  4 week period (per-post)

• upper limb function assessed using the Box and Block test

  upper limb function is assessed using the box and block test where participants are timed while picking up and placing wooden cubes

  4 week period (per-post)

• upper limb motor control assessed using the Fugl-Meyer Assessment-upper extremity

  Upper limb motor control is assessed using a valid and reliable outcome, measure consisting of tasks to be performed by the participant, scores between 0-66, higher scores indicating better motor control.

  4 week period (per-post)

Study Arms (2)

Intervention arm, usual rehabilitation + Jintronix exergame

EXPERIMENTAL

On top of the usual out-patient rehabilitation sessions planned for the participant, participants attend sessions to use the Jintronix system for up 30 minutes up to 3 times per week

Other: Exergame

Control group

OTHER

Participants continue their prescribed rehabilitation sessions

Other: usual care

Interventions

Exergame OTHER

Participants use exergame with the therapist in the rehabilitation center. Several games are available, the therapist adjusts the choice of game and level of difficulty according to the participant's abilities and interests.

Intervention arm, usual rehabilitation + Jintronix exergame

usual care OTHER

participants continued their planned rehabilitation sessions

Control group

Eligibility Criteria

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

You may qualify if:

• having had an ischemic or hemorrhagic stroke for the first time;
• having residual mild to moderate UE impairment (score 3-6 on the Chedoke-McMaster arm component, as long as exergames can be played);
• being in subacute stage (within 6 months post-stroke);
• receiving usual out-patient rehabilitation services at one of the two selected rehabilitation sites, located in the greater Montreal area in Canada.

You may not qualify if:

• being medically unstable;
• having severe cognitive or communication deficits;
• having visual impairments limiting use of the exergame;
• having any medical contraindication for shoulder movements;
• having severe balance deficits limiting sitting safely independently;
• having previous upper limb impairment limiting potential recovery;
• having any other impairment that limited use of the exergame.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Université de Montréal

Montreal, Quebec, H3N 1X7, Canada

Location

MeSH Terms

Conditions

Stroke

Interventions

Exergaming

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: Associate professor

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: March 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: November 30, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)