StrokeNCT02494362
Tele-rehabilitation in the Home With Gaming as a Method of Improving Upper Extremity Function After Stroke
A study testing Computer gaming hand exercise regimen. in people with Stroke and Hemiplegia, run by University of Manitoba at 2 sites in Canada.
Trial summary
The purpose of the study is to determine whether a novel computer gaming hand exercise regimen would improve hand and arm function and be feasible in people with hemiplegia after Stroke affecting the hand. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Computer gaming hand exercise regimen.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2015to May 2017
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Time since stroke onset less than 1 year.
- Ability to actively extend at least 10 degrees at the Metacarpophalangeal and Interphalangeal joints and 10 degrees at the wrist. At least 30 degree of active flexion-extension at elbow and some active movements present at the shoulder joint.
- English speaking.
- No clinical evidence of cognitive impairment (screened by physician or therapist).
- Have a personal computer at home.
- Lives in Winnipeg.
- Able to provide informed consent.
Who cannot join
- Patients having excessive spasticity, pain or contractures in the more affected limb will not be included in the study.
- Convulsive seizures preventing adequate attention to task.
- Problem with vision.
- Aphasia.
- Apraxia.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
School of Medical Rehabilitation , University of Mantioba
Winnipeg, Manitoba, R3e 0T6
Tony Szturm, PT, PhD
- Recruiting
Riverview Health Centre
Winnipeg, Manitoba, R3T 1a3
Sepideh Pooyania, MD, (204) 478-6219, spooyania@rhc.mb.ca
About this study
The purpose of the study is to determine whether a novel computer gaming hand exercise regimen would improve hand and arm function and be feasible in people with hemiplegia after Stroke affecting the hand.
Read the detailed description
A novel computer gaming hand exercise regimen has been designed for people with hemiplegia after Stroke affecting the hand. The design allows a broad range of common objects of daily life to be seamlessly transformed into 'therapeutic' input devices by instrumenting with a small motion sense mouse. Based on individual abilities and treatment needs, objects are selected to train specific fine/ gross dexterous functions. The object manipulations (therapeutic exercises) are then used to control and play any commercially available computer game, making practice challenging and engaging.
The study is of twelve weeks duration comparing the computer gaming and conventional hand exercises in ten people with hemiplegia after Stroke affecting the hand. The investigators hypothesize that the game based exercises will improve hand function and will be feasible. A mixed-effect repeated measures analysis of variance will be conducted to test pre to post treatment outcomes.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Computer gaming hand exercise regimen.
- Keywords
- Hand exercises, Hand function, Computer based exercises, Therapeutic gaming
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer gaming hand exercise regimen.Other
Computer gaming hand exercise regimen using common objects of daily life. The hand exercises are coupled with commercially available computer games and will be performed 30 minutes,four times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Computer gaming hand exercise regimen. Receives: Other: Computer gaming hand exercise regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test (Change is being assessed)
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Stroke Impact Scale (Change is being assessed)
Measured: Baseline and 12 weeks
Change from baseline in Paddle game based hand function assessment tool from baseline and 12 weeks.
A novel, paddle game based hand function assessment tool has been developed designed to: 1) Objectively quantify the quality of finger hand movements (task performance) during manipulation of broad range of common objects independent of physical properties, anatomical requirements and task goal/context, 2) Track changes in finger hand function over time and 3) Aid in clinical decision making.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Tony Szturm, University of Manitoba
- Investigators
- Tony Szturm, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494362
- Sponsor's protocol ID
- H2015
- Status last verified
- May 2016
- First submitted
- 22 May 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Szturm T, Peters JF, Otto C, Kapadia N, Desai A. Task-specific rehabilitation of finger-hand function using interactive computer gaming. Arch Phys Med Rehabil. 2008 Nov;89(11):2213-7. doi: 10.1016/j.apmr.2008.04.021.
PubMed 18996252Lockery D, Peters JF, Ramanna S, Shay BL, Szturm T. Store-and-feedforward adaptive gaming system for hand-finger motion tracking in telerehabilitation. IEEE Trans Inf Technol Biomed. 2011 May;15(3):467-73. doi: 10.1109/TITB.2011.2125976.
PubMed 21536526Andersen Hammond ER, Shay BL, Szturm T. Objective evaluation of fine motor manipulation-a new clinical tool. J Hand Ther. 2009 Jan-Mar;22(1):28-35; quiz 36. doi: 10.1197/j.jht.2008.06.006. Epub 2008 Aug 30.
PubMed 18950989
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-rehabilitation in the Home With Gaming as a Method of Improving Upper Extremity Function After Stroke
- ClinicalTrials.gov ID
- NCT02494362
- Acronym / sponsor ID
- H2015
- Conditions
- Stroke, Hemiplegia
- Keywords
- Hand exercises, Hand function, Computer based exercises, Therapeutic gaming
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether a novel computer gaming hand exercise regimen would improve hand and arm function and be feasible in people with hemiplegia after Stroke affecting the hand.
Detailed description
A novel computer gaming hand exercise regimen has been designed for people with hemiplegia after Stroke affecting the hand. The design allows a broad range of common objects of daily life to be seamlessly transformed into 'therapeutic' input devices by instrumenting with a small motion sense mouse. Based on individual abilities and treatment needs, objects are selected to train specific fine/ gross dexterous functions. The object manipulations (therapeutic exercises) are then used to control and play any commercially available computer game, making practice challenging and engaging.
The study is of twelve weeks duration comparing the computer gaming and conventional hand exercises in ten people with hemiplegia after Stroke affecting the hand. The investigators hypothesize that the game based exercises will improve hand function and will be feasible. A mixed-effect repeated measures analysis of variance will be conducted to test pre to post treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Computer gaming hand exercise regimen.Computer gaming hand exercise regimen. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Time since stroke onset less than 1 year.
- Ability to actively extend at least 10 degrees at the Metacarpophalangeal and Interphalangeal joints and 10 degrees at the wrist. At least 30 degree of active flexion-extension at elbow and some active movements present at the shoulder joint.
- English speaking.
- No clinical evidence of cognitive impairment (screened by physician or therapist).
- Have a personal computer at home.
Key exclusion criteria (5 listed)
- Patients having excessive spasticity, pain or contractures in the more affected limb will not be included in the study.
- Convulsive seizures preventing adequate attention to task.
- Problem with vision.
- Aphasia.
- Apraxia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer gaming hand exercise regimen.Computer gaming hand exercise regimen using common objects of daily life. The hand exercises are coupled with commercially available computer games and will be performed 30 minutes,four times per week for 12 weeks. | Other | Experimental Group |
Primary outcome
Wolf Motor Function Test (Change is being assessed)
Time frame: Baseline and 12 weeks
2 secondary outcomes
Stroke Impact Scale (Change is being assessed)
Time frame: Baseline and 12 weeks
Change from baseline in Paddle game based hand function assessment tool from baseline and 12 weeks.
Time frame: Baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 18996252Szturm T, Peters JF, Otto C, Kapadia N, Desai A. Task-specific rehabilitation of finger-hand function using interactive computer gaming. Arch Phys Med Rehabil. 2008 Nov;89(11):2213-7. doi: 10.1016/j.apmr.2008.04.021.
- Background: PubMed 21536526Lockery D, Peters JF, Ramanna S, Shay BL, Szturm T. Store-and-feedforward adaptive gaming system for hand-finger motion tracking in telerehabilitation. IEEE Trans Inf Technol Biomed. 2011 May;15(3):467-73. doi: 10.1109/TITB.2011.2125976.
- Background: PubMed 18950989Andersen Hammond ER, Shay BL, Szturm T. Objective evaluation of fine motor manipulation-a new clinical tool. J Hand Ther. 2009 Jan-Mar;22(1):28-35; quiz 36. doi: 10.1197/j.jht.2008.06.006. Epub 2008 Aug 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Szturm, PhD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer gaming hand exercise regimen. in people with Stroke and Hemiplegia, run by University of Manitoba at 2 sites 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tony Szturm, PhD (204-789-3897, tony.szturm@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (Change is being assessed) (time frame: Baseline and 12 weeks). 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 NCT02494362, which also lists 3 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 13 May 2016; AzTrials last refreshed its copy on 6 Nov 2026.