Primary Progressive Multiple SclerosisNCT03094364
Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis
A study testing Gaming CI Therapy in people with Primary Progressive Multiple Sclerosis and Hemiparesis, run by University of Massachusetts, Lowell at 1 site in United States.
Trial summary
Participants will receive intensive therapy through a video game in their own homes for 1 month. The game is operated by movements of the body (no controller needed) and acts like a virtual therapist. Participants will agree to play the game for 30 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Progressive Multiple Sclerosis, Hemiparesis
- What is being tested?
- Gaming CI Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 31 Oct 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
- Patients who have progressive multiple sclerosis resulting in upper extremity motor impairment.
- Have the ability to comprehend and participate in basic elements of the therapy.
- Have substantial non-use in the more affected upper extremity.
Who cannot join
- Are currently participating in other experimental trials.
- Are currently participating in additional upper extremity therapy.
- Experienced relapse within the past 6 months.
- Too frail to undergo intensive rehabilitation,
- Those with serious, uncontrolled medical problems.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University, 2154 Dodd Hall
Columbus, Ohio, 43210
About this study
Participants will receive intensive therapy through a video game in their own homes for 1 month. The game is operated by movements of the body (no controller needed) and acts like a virtual therapist. Participants will agree to play the game for 30 hours. They will also receive 4 home visits from a therapist designed to increase use of their arm for daily activities that are important to them. Participants will also receive a smart watch that will measure use of their weaker arm and alert them when their arm is not participating in activities. Arm strength and function will be measured before and after the therapy program.
Read the detailed description
Randomized waitlist control trial. One group will receive treatment immediately (50%) and the other group will receive treatment following a three-week delay (50%). Group 1 will be assessed by physical/occupational therapists and rehabilitation psychologists (blinded to treatment phase) before and after the virtual gaming treatment. Group 2 will receive two baseline assessments (baseline followed by three weeks of usual and customary care and then another baseline before starting the gaming treatment), and again after three weeks of virtual gaming treatment.
- Being tested
- Gaming CI Therapy
- Keywords
- Constraint-induced movement therapy, video game, virtual reality, upper extremity, CI therapy, rehabilitation, hemiparesis, MS, multiple sclerosis, progressive multiple sclerosis, primary progressive multiple sclerosis, secondary progressive multiple sclerosis, motor, physical therapy, physiotherapy, occupational therapy, arm, hand
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Paresis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaming CI TherapyBehavioural
Intensive remote (via video game) therapy for upper extremity hemiparesis.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Active comparator | Patients will receive an in-home consultation with an occupational/physical therapist in which they are educated about the intervention, the system is set up, and they are guided through use of the system. After initial contact, therapist support will be available via telephone to address specific difficulties with operating the system, as well as three additional home visits throughout the 3 week intervention.
The rehabilitation program requires use of the rehabilitation gaming system for 1.5 hours daily for 21 consecutive days (equivalent dosage to standard CI therapy), limb activation device worn for 90% of waking hours, and completion of the automated transfer package to facilitate real-world arm use (e.g., problem-solving modules, daily monitoring of arm use). After completing the intervention, the patient will receive additional consultation with the therapist to formulate goals for follow-up. Follow-up assessments will be conducted to assess long-term retention of motor gains. Receives: Behavioral: Gaming CI Therapy |
| Delayed Treatment | Active comparator | Patients will receive an in-home consultation with an occupational/physical therapist in which they are educated about the intervention, the system is set up, and they are guided through use of the system. After initial contact, therapist support will be available via telephone to address specific difficulties with operating the system, as well as three additional home visits throughout the 3 week intervention.
The rehabilitation program requires use of the rehabilitation gaming system for 1.5 hours daily for 21 consecutive days (equivalent dosage to standard CI therapy), limb activation device worn for 90% of waking hours, and completion of the automated transfer package to facilitate real-world arm use (e.g., problem-solving modules, daily monitoring of arm use). After completing the intervention, the patient will receive additional consultation with the therapist to formulate goals for follow-up. Follow-up assessments will be conducted to assess long-term retention of motor gains. Receives: Behavioral: Gaming CI Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral Activity Monitors (Accelerometers)
Devices to monitor upper extremity movement throughout treatment
Measured: 0 to 1 Months
Wolf Motor Function Test
Assessment to evaluate motor function
Measured: 0 to 1 Months
Secondary outcomes (6)
Biomechanical Measures
Recorded during game play through limb activation device and Kinect
Measured: 0 to 1 Months
Multiple Sclerosis Impact Scale (MSIS-29)
Scale to asses living with MS
Measured: 0 to 1 Months
Short form-36 Health Survey
Survey
Measured: 0 to 1 Months
Neuro-QOL
Assessment to measure quality of life
Measured: 0 to 1 Months
Patient Health Questionnaire (PHQ-9)
Measured: 0 to 1 Months
Montreal Cognitive Assessment (MoCA)
Assessment to measure cognitive function
Measured: 0 to 1 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study startNov 2015
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive Multiple SclerosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Lowell
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Lynne Gauthier, University of Massachusetts, Lowell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094364
- Sponsor's protocol ID
- 60052127
- Status last verified
- Apr 2019
- First submitted
- 23 Mar 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made public 1 year after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Game-based Therapy for Arm Weakness In Progressive Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03094364
- Acronym / sponsor ID
- 60052127
- Keywords
- Constraint-induced movement therapy, video game, virtual reality, upper extremity, CI therapy, rehabilitation, hemiparesis, MS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Massachusetts, LowellUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Nov 2015
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 29 Mar 2017 (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.
Participants will receive intensive therapy through a video game in their own homes for 1 month. The game is operated by movements of the body (no controller needed) and acts like a virtual therapist. Participants will agree to play the game for 30 hours. They will also receive 4 home visits from a therapist designed to increase use of their arm for daily activities that are important to them. Participants will also receive a smart watch that will measure use of their weaker arm and alert them when their arm is not participating in activities. Arm strength and function will be measured before and after the therapy program.
Detailed description
Randomized waitlist control trial. One group will receive treatment immediately (50%) and the other group will receive treatment following a three-week delay (50%). Group 1 will be assessed by physical/occupational therapists and rehabilitation psychologists (blinded to treatment phase) before and after the virtual gaming treatment. Group 2 will receive two baseline assessments (baseline followed by three weeks of usual and customary care and then another baseline before starting the gaming treatment), and again after three weeks of virtual gaming treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Active comparator | Behavioral: Gaming CI TherapyPatients will receive an in-home consultation with an occupational/physical therapist in which they are educated about the intervention, the system is set up, and they are guided through use of the system. After initial contact, therapist support will be available via telephone to address specific difficulties with operating the system, as well as three additional home visits throughout the 3 week intervention. The rehabilitation program requires use of the rehabilitation gaming system for 1.5 hours daily for 21 consecutive days (equivalent dosage to standard CI therapy), limb activation device worn for 90% of waking hours, and completion of the automated transfer package to facilitate real-world arm use (e.g., problem-solving modules, daily monitoring of arm use). After completing the intervention, the patient will receive additional consultation with the therapist to formulate goals for follow-up. Follow-up assessments will be conducted to assess long-term retention of motor gains. |
| Delayed Treatment | Active comparator | Behavioral: Gaming CI TherapyPatients will receive an in-home consultation with an occupational/physical therapist in which they are educated about the intervention, the system is set up, and they are guided through use of the system. After initial contact, therapist support will be available via telephone to address specific difficulties with operating the system, as well as three additional home visits throughout the 3 week intervention. The rehabilitation program requires use of the rehabilitation gaming system for 1.5 hours daily for 21 consecutive days (equivalent dosage to standard CI therapy), limb activation device worn for 90% of waking hours, and completion of the automated transfer package to facilitate real-world arm use (e.g., problem-solving modules, daily monitoring of arm use). After completing the intervention, the patient will receive additional consultation with the therapist to formulate goals for follow-up. Follow-up assessments will be conducted to assess long-term retention of motor gains. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have progressive multiple sclerosis resulting in upper extremity motor impairment.
- Have the ability to comprehend and participate in basic elements of the therapy.
- Have substantial non-use in the more affected upper extremity.
Key exclusion criteria (5 listed)
- Are currently participating in other experimental trials.
- Are currently participating in additional upper extremity therapy.
- Experienced relapse within the past 6 months.
- Too frail to undergo intensive rehabilitation,
- Those with serious, uncontrolled medical problems.
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 |
|---|---|---|
| Gaming CI TherapyIntensive remote (via video game) therapy for upper extremity hemiparesis. | Behavioural | Delayed Treatment, Immediate Treatment |
Primary outcome
Bilateral Activity Monitors (Accelerometers)
Time frame: 0 to 1 Months
Devices to monitor upper extremity movement throughout treatment
Wolf Motor Function Test
Time frame: 0 to 1 Months
Assessment to evaluate motor function
6 secondary outcomes
Biomechanical Measures
Time frame: 0 to 1 Months
Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: 0 to 1 Months
Short form-36 Health Survey
Time frame: 0 to 1 Months
Neuro-QOL
Time frame: 0 to 1 Months
Patient Health Questionnaire (PHQ-9)
Time frame: 0 to 1 Months
Montreal Cognitive Assessment (MoCA)
Time frame: 0 to 1 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: Yes. Data will be made public 1 year after study completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaming CI Therapy in people with Primary Progressive Multiple Sclerosis and Hemiparesis, run by University of Massachusetts, Lowell at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 18 Apr 2019. 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 United States. 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?
Bilateral Activity Monitors (Accelerometers) (time frame: 0 to 1 Months). The study lists 2 primary outcomes in all. 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 18 Apr 2019.