Spinal Muscular AtrophyINFORM SMANCT06396325
A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy
A study testing Tales from the Magic Keep™ in people with Spinal Muscular Atrophy, run by Maryam Oskoui, MD, MSc, FRCPC, FAAN at 5 sites in Canada.
Trial summary
This is a multisite randomized controlled registry-based trial to evaluate the efficacy of an 8-week home-based exergaming intervention as compared to usual care on occupational satisfaction of children and youth (8-18 years old age) with spinal muscular atrophy (SMA). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Spinal Muscular Atrophy
- What is being tested?
- Tales from the Magic Keep™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesCanada
- Study dates
- 1 Nov 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed genetic diagnosis of 5q SMA
- Age at screening: Aged 8-18 years old
- Participant is able to stay seated independently without support for at least 10 seconds
- Participants has a score of at least 2 points in entry item A of the RULM (i.e., "Can raise 1 or 2 hands to the mouth but cannot raise a 200 g weight in it to the mouth")
- Treated with disease-modifying therapy
- Signed ICF
Who cannot join
- Inability to comply with study procedures according to the site investigator, prior to randomization
- Severe scoliosis or contractures that would interfere with gameplay or with successful completion of functional assessments, as confirmed by the clinical evaluator
- Planned orthopedic surgery 6 months prior to or throughout intervention and follow-up period (16 weeks post randomization)
- Inability to read in English or French
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta
Julie Dao, 403-955-7211 ext. 7132, Julie.dao@ucalgary.ca
Jean Mah
- Recruiting
IWK Health Services
Halifax, Nova Scotia
Sara Drisdelle, 902-789-1599, sara.drisdelle@iwk.nshealth.ca
Jordan Sheriko
- Recruiting
Centre de readaptation Marie-Enfant
Montreal, Quebec
Evemie Dube, 514 374-1710 ext. 8601, evemie.dube.hsj@ssss.gouv.qc.ca
Danielle Levac
- Recruiting
Hospital for SickKids
Toronto, Ontario
Ana Stosic, 416-813-7654 ext. 309965, ana.stosic@sickkids.ca
Hernan Gonorazky
- Recruiting
BC Children's Hospital
Vancouver, British Columbia
Alex Salvarinov, 604 875 2345 ext. 7132, alex.salvarinov@cw.bc.ca
Kathryn Selby
About this study
Official title: A Registry-Based Parallel Group Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy, With an Optional Open-Label Extension
This is a multisite randomized controlled registry-based trial to evaluate the efficacy of an 8-week home-based exergaming intervention as compared to usual care on occupational satisfaction of children and youth (8-18 years old age) with spinal muscular atrophy (SMA).
Read the detailed description
This multisite randomized controlled registry-based trial will evaluate the efficacy of a home-based exergaming intervention, as compared to usual care, on occupational satisfaction of children and youth (aged 8-18 years old) with SMA. Participants in the intervention arm will play the exergame, Tales from the Magic Keep™ on the Azure Kinect platform, 3 times per week, for at least 20 minutes, over 8 weeks (total 8 hours), and continue to access their regular physical activities and rehabilitation services. Those in the usual care arm will continue to access their regular physical activities and rehabilitation services. Occupational satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM) at 8 weeks.
- Conditions
- Spinal Muscular Atrophy
- Being tested
- Tales from the Magic Keep™, Usual Care
- Keywords
- spinal muscular atrophy, rehabilitation, Exergaming, Pediatrics, Randomized-controlled trial
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tales from the Magic Keep™Other
Exergame targeting upper limb and trunk movement designed for use on the Microsoft Azure Kinect Dose: At least 3 times a week for 20 minutes over 8 weeks (8 hours total) Continue with regularly accessed physical activities and rehabilitation services
Usual CareOther
Continue with regularly accessed physical activities and rehabilitation services
| Study group | Role | What they receive |
|---|---|---|
| Exergaming Intervention for 8 Weeks | Experimental | Extension Phase: Participants randomized ot the intervention arm will play Tales from the Magic Keep at home for the 8 week open-label extension phase Receives: Other: Tales from the Magic Keep™ |
| Usual Care for 8 weeks. | Active comparator | Extension Phase: Participants randomized to waitlist usual care will play Tales from the Magic Keep at home for the 8 week open-label extension phase Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with occupational performance
Canadian Occupational Performance Measure (COPM) Satisfaction
Measured: Baseline to 16 weeks
Secondary outcomes (3)
Self-reported fatigue
Patient-Reported Outcomes Measurement Information System (PROMIS-SF)
Measured: Baseline to 16 weeks
Independence performing activities of daily living
SMA Independence Scale (SMAIS)
Measured: Baseline to 16 weeks
Upper limb motor activity
Median and 99th percentile of upper limb rotational effort and vertical wrist acceleration derived from data captured by the Syde wearable device
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Nov 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular AtrophyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maryam Oskoui, MD, MSc, FRCPC, FAAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maryam Oskoui, MD, MSc, FRCPC, FAAN, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Maryam Oskoui, Principal investigator, McGill UniversityDanielle Levac, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396325
- Sponsor's protocol ID
- MP-37-2022-7289
- Acronym
- INFORM SMA
- Status last verified
- Jul 2025
- First submitted
- 29 Apr 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry-Based Parallel Group Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy, With an Optional Open-Label Extension
- ClinicalTrials.gov ID
- NCT06396325
- Acronym / sponsor ID
- INFORM SMA / MP-37-2022-7289
- Conditions
- Spinal Muscular Atrophy
- Keywords
- spinal muscular atrophy, rehabilitation, Exergaming, Pediatrics, Randomized-controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Maryam Oskoui, MD, MSc, FRCPC, FAANUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 May 2024 (actual)
- 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.
This is a multisite randomized controlled registry-based trial to evaluate the efficacy of an 8-week home-based exergaming intervention as compared to usual care on occupational satisfaction of children and youth (8-18 years old age) with spinal muscular atrophy (SMA).
Detailed description
This multisite randomized controlled registry-based trial will evaluate the efficacy of a home-based exergaming intervention, as compared to usual care, on occupational satisfaction of children and youth (aged 8-18 years old) with SMA. Participants in the intervention arm will play the exergame, Tales from the Magic Keep™ on the Azure Kinect platform, 3 times per week, for at least 20 minutes, over 8 weeks (total 8 hours), and continue to access their regular physical activities and rehabilitation services. Those in the usual care arm will continue to access their regular physical activities and rehabilitation services. Occupational satisfaction will be assessed using the Canadian Occupational Performance Measure (COPM) at 8 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exergaming Intervention for 8 Weeks | Experimental | Other: Tales from the Magic Keep™Extension Phase: Participants randomized ot the intervention arm will play Tales from the Magic Keep at home for the 8 week open-label extension phase |
| Usual Care for 8 weeks. | Active comparator | Other: Usual CareExtension Phase: Participants randomized to waitlist usual care will play Tales from the Magic Keep at home for the 8 week open-label extension phase |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Confirmed genetic diagnosis of 5q SMA
- Age at screening: Aged 8-18 years old
- Participant is able to stay seated independently without support for at least 10 seconds
- Participants has a score of at least 2 points in entry item A of the RULM (i.e., "Can raise 1 or 2 hands to the mouth but cannot raise a 200 g weight in it to the mouth")
- Treated with disease-modifying therapy
Key exclusion criteria (4 listed)
- Inability to comply with study procedures according to the site investigator, prior to randomization
- Severe scoliosis or contractures that would interfere with gameplay or with successful completion of functional assessments, as confirmed by the clinical evaluator
- Planned orthopedic surgery 6 months prior to or throughout intervention and follow-up period (16 weeks post randomization)
- Inability to read in English or French
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 |
|---|---|---|
| Tales from the Magic Keep™Exergame targeting upper limb and trunk movement designed for use on the Microsoft Azure Kinect Dose: At least 3 times a week for 20 minutes over 8 weeks (8 hours total) Continue with regularly accessed physical activities and rehabilitation services | Other | Exergaming Intervention for 8 Weeks |
| Usual CareContinue with regularly accessed physical activities and rehabilitation services | Other | Usual Care for 8 weeks. |
Primary outcome
Satisfaction with occupational performance
Time frame: Baseline to 16 weeks
Canadian Occupational Performance Measure (COPM) Satisfaction
3 secondary outcomes
Self-reported fatigue
Time frame: Baseline to 16 weeks
Independence performing activities of daily living
Time frame: Baseline to 16 weeks
Upper limb motor activity
Time frame: Baseline to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Maryam Oskoui principal investigator
McGill University
Danielle Levac principal investigator
Université de Montréal
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tales from the Magic Keep™ in people with Spinal Muscular Atrophy, run by Maryam Oskoui, MD, MSc, FRCPC, FAAN at 5 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mbaye Ndiaye (5149341934 ext. 37299, mbaye.ndiaye@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with occupational performance (time frame: Baseline to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2025.