Multiple SclerosisNCT06506929
Task Specific Training for Advanced Multiple Sclerosis
A study testing Task specific physical therapy in people with Multiple Sclerosis, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
The purpose of this study is to find effective physical therapy treatments for individuals who have severe multiple sclerosis. Physical therapy treatments for mild-to-moderate multiple sclerosis exists, however, very limited research has been done for physical therapy for severe multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Task specific physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to Jan 2026
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- definitive diagnosis of Multiple Sclerosis
- Expanded Disability Status Scale (EDSS) of 7.0-8.0
- Ability to read, understand , and sign an informed consent -
Who cannot join
- evidence of MS exacerbation in the 4 weeks prior to starting the study
- any orthopedic, cardiopulmonary, or non-MS neurologic symptoms that will interfere with their ability to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hunter College, Physical Therapy Department, City University of New York
New York, New York, 10010
Herbert Karpatkin, DSc, 212-396-7115, hkarpatk@hunter.cuny.edu
Arita Winter, 212-650-3053, aw4338@hunter.cuny.edu
About this study
Official title: The Effect of Task Specific Physical Therapy for Persons With Advanced Multiple Sclerosis
The purpose of this study is to find effective physical therapy treatments for individuals who have severe multiple sclerosis. Physical therapy treatments for mild-to-moderate multiple sclerosis exists, however, very limited research has been done for physical therapy for severe multiple sclerosis (MS). In this study 10 participants diagnosed with severe MS will engage in 1-hour physical therapy sessions twice a week for 6 weeks to address limitations in standing, balancing, and bed mobility.
Read the detailed description
The purpose of this study is to investigate the feasibility, safety, and efficacy of task-specific physical therapy for persons with severe MS. The hypothesize for this study that a task-specific physical therapy program is safe, feasible, and effective in persons with severe MS.
Multiple studies have confirmed the effectiveness of task specific physical therapy for persons with MS. However,MS is a progressive disease which can lead to mild to severe disability and the studies examining the effectiveness of task specific therapy have only been conducted on persons with mild to moderate MS impairments. The small amount of research on physical therapy for persons with severe disability due to MS has only looked at the use of generalized conditioning exercises(1). Task specific therapy has been shown to be effective in persons with severe disability in non-MS neurologic disorders.(2) The effectiveness of task specific exercises on persons with severe MS not been studied. Based on the previous scientific evidence of the effectiveness of task-specific physical therapy in MS subjects with mild-to-moderate disability, there is strong scientific justification for conducting a trial of task specific therapy on persons with severe disability due to MS.
The results of this study will be presented at various conferences attended by physical therapists as well as other health care practitioners who specialize in MS care, including the American Physical Therapy Combined Sections Meeting, as well as the Consortium of Multiple Sclerosis Centers annual meeting. Additionally, upon completion of the study, we will submit a manuscript to the appropriate peer review journal.
- Conditions
- Multiple Sclerosis
- Being tested
- Task specific physical therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task specific physical therapyOther
Physical Therapy based specifically on tasks that the participant os having difficulty with
| Study group | Role | What they receive |
|---|---|---|
| Task specific Physical Therapy | Experimental | Participants will received task specific physical therapy for 1 hour, twice a week for 6 weeks Receives: Other: Task specific physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA)
Assessment of ability to perform functional mobility tasks. The MSPFFA is a 14 item ordinal scale; the maximum score is a 56, minimom score is 14. The higher the score, the better the function and the less physically frail the person being tested is considered to be.
Measured: Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.
Secondary outcomes (1)
Multiple Sclerosis Impact Scale-29 (MSIS29)
Self report measure of the impact of MS on the participant. The MSIS-29 is 29 item self report measure. The higher the score, the greater the impact of MS on the person person reporting bleives they have.The score is rated from 0-100 with the higher score indicating a greater impact on the individual from MS.
Measured: Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start10 Jul 2024
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study- single group pretest postest
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Foundation
- Responsible party
- Principal investigator, Herb Karpatkin, Hunter College of City University of New York
- Investigators
- Herbert Karpatkin, Principal investigator, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506929
- Sponsor's protocol ID
- 2024-0303
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In addition to Individual Participant Data (IPD) the following information will be shared Study Protocol
Publications
Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski K, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Mult Scler. 2020 Oct;26(12):1459-1469. doi: 10.1177/1352458520915629. Epub 2020 Apr 23.
PubMed 32323606Arya KN, Verma R, Garg RK, Sharma VP, Agarwal M, Aggarwal GG. Meaningful task-specific training (MTST) for stroke rehabilitation: a randomized controlled trial. Top Stroke Rehabil. 2012 May-Jun;19(3):193-211. doi: 10.1310/tsr1903-193.
PubMed 22668675
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Task Specific Physical Therapy for Persons With Advanced Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06506929
- Acronym / sponsor ID
- 2024-0303
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Foundation
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 18 Jul 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.
The purpose of this study is to find effective physical therapy treatments for individuals who have severe multiple sclerosis. Physical therapy treatments for mild-to-moderate multiple sclerosis exists, however, very limited research has been done for physical therapy for severe multiple sclerosis (MS). In this study 10 participants diagnosed with severe MS will engage in 1-hour physical therapy sessions twice a week for 6 weeks to address limitations in standing, balancing, and bed mobility.
Detailed description
The purpose of this study is to investigate the feasibility, safety, and efficacy of task-specific physical therapy for persons with severe MS. The hypothesize for this study that a task-specific physical therapy program is safe, feasible, and effective in persons with severe MS.
Multiple studies have confirmed the effectiveness of task specific physical therapy for persons with MS. However,MS is a progressive disease which can lead to mild to severe disability and the studies examining the effectiveness of task specific therapy have only been conducted on persons with mild to moderate MS impairments. The small amount of research on physical therapy for persons with severe disability due to MS has only looked at the use of generalized conditioning exercises(1). Task specific therapy has been shown to be effective in persons with severe disability in non-MS neurologic disorders.(2) The effectiveness of task specific exercises on persons with severe MS not been studied. Based on the previous scientific evidence of the effectiveness of task-specific physical therapy in MS subjects with mild-to-moderate disability, there is strong scientific justification for conducting a trial of task specific therapy on persons with severe disability due to MS.
The results of this study will be presented at various conferences attended by physical therapists as well as other health care practitioners who specialize in MS care, including the American Physical Therapy Combined Sections Meeting, as well as the Consortium of Multiple Sclerosis Centers annual meeting. Additionally, upon completion of the study, we will submit a manuscript to the appropriate peer review journal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study- single group pretest postest
| Arm | Type | Receives |
|---|---|---|
| Task specific Physical Therapy | Experimental | Other: Task specific physical therapyParticipants will received task specific physical therapy for 1 hour, twice a week for 6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- definitive diagnosis of Multiple Sclerosis
- Expanded Disability Status Scale (EDSS) of 7.0-8.0
- Ability to read, understand , and sign an informed consent -
Key exclusion criteria (2 listed)
- evidence of MS exacerbation in the 4 weeks prior to starting the study
- any orthopedic, cardiopulmonary, or non-MS neurologic symptoms that will interfere with their ability to participate in the study
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 |
|---|---|---|
| Task specific physical therapyPhysical Therapy based specifically on tasks that the participant os having difficulty with | Other | Task specific Physical Therapy |
Primary outcome
Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA)
Time frame: Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.
Assessment of ability to perform functional mobility tasks. The MSPFFA is a 14 item ordinal scale; the maximum score is a 56, minimom score is 14. The higher the score, the better the function and the less physically frail the person being tested is considered to be.
1 secondary outcome
Multiple Sclerosis Impact Scale-29 (MSIS29)
Time frame: Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Background: PubMed 32323606Kalb R, Brown TR, Coote S, Costello K, Dalgas U, Garmon E, Giesser B, Halper J, Karpatkin H, Keller J, Ng AV, Pilutti LA, Rohrig A, Van Asch P, Zackowski K, Motl RW. Exercise and lifestyle physical activity recommendations for people with multiple sclerosis throughout the disease course. Mult Scler. 2020 Oct;26(12):1459-1469. doi: 10.1177/1352458520915629. Epub 2020 Apr 23.
- Background: PubMed 22668675Arya KN, Verma R, Garg RK, Sharma VP, Agarwal M, Aggarwal GG. Meaningful task-specific training (MTST) for stroke rehabilitation: a randomized controlled trial. Top Stroke Rehabil. 2012 May-Jun;19(3):193-211. doi: 10.1310/tsr1903-193.
- Individual participant dataSharing planned: Yes. In addition to Individual Participant Data (IPD) the following information will be shared Study Protocol
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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.
Herbert Karpatkin principal investigator
Hunter College of City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task specific physical therapy in people with Multiple Sclerosis, run by Hunter College of City University of New York 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 2 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 19 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herbert Karpatkin, DSc (212-396-7115, hkarpatkin@hunter.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA) (time frame: Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 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 NCT06506929, which also lists 2 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 19 Jul 2024.