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Recruiting
View on ClinicalTrials.gov

Testing Tales from the Magic Keep™ for spinal muscular atrophy

Official title: A Registry Based Randomized-Controlled Trial of an Upper Limb Exergaming Intervention for Children and Adolescents With Spinal Muscular Atrophy

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

Condition: Spinal Muscular AtrophySponsor: Maryam Oskoui, MD, MSc, FRCPC, FAANTarget enrollment: 22
  • 2 groups
  • Sites in Calgary, Vancouver and 3 more cities
  • Recruiting
Alberta Children's Hospital, Calgary, AlbertaBC Children's Hospital, Vancouver, British ColumbiaIWK Health Services, Halifax, Nova ScotiaHospital for SickKids, Toronto, OntarioCentre de readaptation Marie-Enfant, Montreal, Quebec

Interventions

  • Other intervention

    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 intervention

    Usual Care

    Continue with regularly accessed physical activities and rehabilitation services

Canadian Sites (5)

5 of 5 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta

    Recruiting
  • BC Children's Hospital

    Vancouver, British Columbia

    Recruiting
  • IWK Health Services

    Halifax, Nova Scotia

    Recruiting

Eligibility Criteria

See who this study is looking for10 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Age at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →: Aged 8-18 years old
  • +Confirmed genetic diagnosis of 5q SMA
  • +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 ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more →

Exclusion

  • Inability to comply with study procedures according to the siteTrial siteA hospital or clinic where a study is actually run.Read more → investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
  • Severe scoliosis or contractures that would interfere with gameplay or with successful completion of functional assessments, as confirmed by the clinical evaluator
  • Inability to read in English or French
  • Planned orthopedic surgery 6 months prior to or throughout intervention and follow-up periodFollow-upContinued check-ins after the treatment part is finished.Read more → (16 weeks post randomization)
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to improve comfort and quality of life alongside other care.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Tales from the Magic Keep™.

Registry label: A: Exergaming Intervention for 8 Weeks

Group B, the comparison group, receives Usual CareStandard of careThe treatment normally given for a condition outside a study.Read more →.

Registry label: B: Usual Care for 8 weeks.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 8 years to 18 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 22 people.

The study is currently expected to finish around December 2027.

The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to 16 weeks.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Satisfaction with occupational performance — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to 16 weeks.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06396325 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About 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

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Usual CareOther

Continue with regularly accessed physical activities and rehabilitation services

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 8 years to 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 8 years to 18 years.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → to 16 weeks.

The study as a whole is currently expected to finish around 2027-12-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 22 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 5 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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).

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.