Multiple SclerosisNCT06486116
Effectiveness of Task Specific Home Exercise Program
A study testing Task Specific Physical Therapy Home Program in people with Multiple Sclerosis, run by New York Presbyterian Brooklyn Methodist Hospital at 1 site in United States.
Trial summary
The purpose of this study is to compare the effectiveness of 2 different types of Home Exercise Programs (HEP) on mobility in persons with Multiple Sclerosis (MS). Specifically, we will be comparing the Standard of Care (SOC) a program based on aerobic conditioning and calisthenics to a Task Specific Program (TSP). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Task Specific Physical Therapy Home Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 31 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Definitive diagnosis of Multiple sclerosis
- Ability to walk for at least 30 seconds unassisted with or without assistive device
- Ability to read, comprehend and sign an informed consent
- Is able to attend a 2 outpatient evaluation sessions 6 weeks apart
- Between the ages of 18 and 75
Who cannot join
- Evidence of recent MS exacerbation
- Any orthopedic, cardiopulmonary, or non- MS neurologic condition that prohibits participation in a Physical therapy program
- Be currently receiving outpatient physical therapy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Pearlia Fullard, 718-780-5584, pcfullar@nyp.org
Joy J Rutherford, BS, 718-780-7715, jor9147@nyp.org
About this study
The purpose of this study is to compare the effectiveness of 2 different types of Home Exercise Programs (HEP) on mobility in persons with Multiple Sclerosis (MS). Specifically, we will be comparing the Standard of Care (SOC) a program based on aerobic conditioning and calisthenics to a Task Specific Program (TSP).
Primary Question: Will persons with who receive a Task Specific HEP have greater improvement in mobility than those who receive the SOC? Secondary question: Will a task specific HEP be as well tolerated as the SOC HEP by persons with MS
Read the detailed description
Persons with MS have been shown to benefit from exercise to address the symptoms of their disease. Exercise programs are customarily given by Physical Therapists (PT) in either an inpatient or outpatient setting. Outpatient PT is typically augmented with a Home exercise Program (HEP) which is meant to enhance the work that is done directly with the PT. Since the amount of exercise done at home is often greater than what is done with the PT, the HEP is of great importance.
However, the types of exercise that are the most useful for useful for persons with MS has not been established. Previous research has shown that due to the unique ways in which MS can affect the nervous system, exercise programs that may be appropriate for persons without MS may not be ideal for those that have the disease
- Conditions
- Multiple Sclerosis
- Being tested
- Task Specific Physical Therapy Home Program
- 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 Therapy Home ProgramBehavioural
Home exercise program based on specific findings from physical therapy evaluations.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Task Specific Physical Therapy Home Exercise Program | Experimental | Physical Therapy Home Exercise program based on specific outcome measure findings. Receives: Behavioral: Task Specific Physical Therapy Home Program |
| Generic physical therapy home exercise program | Active comparator | Generalized fitness-based exercise program Receives: Behavioral: Task Specific Physical Therapy Home Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
Participant walks at best comfortable pace for 6 consecutive minutes; total distance walked and distance per minute is measured.
Measured: Measured before and after each 4 weeks
The Functional Gait Assessment
A measure of walking balance assessed by participant's performance on specific task.
Measured: Measured before and after each 4 weeks
The Mini Balance Evaluation Systems Test (MBEST)
Assessment of participant balance during reactive anticipatory, dynamic and sensory aspects of balance tasks.
Measured: Measured before and after each 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Brooklyn Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Blitz-Shabbir, New York Presbyterian Brooklyn Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486116
- Sponsor's protocol ID
- 2160034
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available. The specific individual participant data sets are to be shared are, collected IPD, all IPD that underlie results in a publication.
Publications
Ghahfarrokhi MM, Banitalebi E, Negaresh R, Motl RW. Home-Based Exercise Training in Multiple Sclerosis: A Systematic Review with Implications for Future Research. Mult Scler Relat Disord. 2021 Oct;55:103177. doi: 10.1016/j.msard.2021.103177. Epub 2021 Jul 27.
PubMed 34343867Dalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11.
PubMed 19413920Ozkul C, Guclu-Gunduz A, Eldemir K, Apaydin Y, Gulsen C, Yazici G, Soke F, Irkec C. Effect of task-oriented circuit training on motor and cognitive performance in patients with multiple sclerosis: A single-blinded randomized controlled trial. NeuroRehabilitation. 2020;46(3):343-353. doi: 10.3233/NRE-203029.
PubMed 32310197McGuigan C, Hutchinson M. The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure. J Neurol Neurosurg Psychiatry. 2004 Feb;75(2):266-9.
PubMed 14742602Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
PubMed 2803071Goldman MD, Ward MD, Motl RW, Jones DE, Pula JH, Cadavid D. Identification and validation of clinically meaningful benchmarks in the 12-item Multiple Sclerosis Walking Scale. Mult Scler. 2017 Sep;23(10):1405-1414. doi: 10.1177/1352458516680749. Epub 2016 Dec 7.
PubMed 27903937Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.
PubMed 16372431Forsberg A, Andreasson M, Nilsagard Y. The Functional Gait Assessment in People with Multiple Sclerosis: Validity and Sensitivity to Change. Int J MS Care. 2017 Mar-Apr;19(2):66-72. doi: 10.7224/1537-2073.2015-061.
PubMed 32607064Potter K, Bowling R, Kavanagh L, Stone A, Witt B, Wooldridge A. Reliability, Validity, and Responsiveness of the Mini-Balance Evaluation Systems Test in Ambulatory Individuals with Multiple Sclerosis. Physiother Can. 2019 Fall;71(4):327-334. doi: 10.3138/ptc-2018-0071.
PubMed 31762543
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Task Specific Home Exercise Program
- ClinicalTrials.gov ID
- NCT06486116
- Acronym / sponsor ID
- 2160034
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York Presbyterian Brooklyn Methodist HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 3 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 compare the effectiveness of 2 different types of Home Exercise Programs (HEP) on mobility in persons with Multiple Sclerosis (MS). Specifically, we will be comparing the Standard of Care (SOC) a program based on aerobic conditioning and calisthenics to a Task Specific Program (TSP).
Primary Question: Will persons with who receive a Task Specific HEP have greater improvement in mobility than those who receive the SOC? Secondary question: Will a task specific HEP be as well tolerated as the SOC HEP by persons with MS
Detailed description
Persons with MS have been shown to benefit from exercise to address the symptoms of their disease. Exercise programs are customarily given by Physical Therapists (PT) in either an inpatient or outpatient setting. Outpatient PT is typically augmented with a Home exercise Program (HEP) which is meant to enhance the work that is done directly with the PT. Since the amount of exercise done at home is often greater than what is done with the PT, the HEP is of great importance.
However, the types of exercise that are the most useful for useful for persons with MS has not been established. Previous research has shown that due to the unique ways in which MS can affect the nervous system, exercise programs that may be appropriate for persons without MS may not be ideal for those that have the disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Task Specific Physical Therapy Home Exercise Program | Experimental | Behavioral: Task Specific Physical Therapy Home ProgramPhysical Therapy Home Exercise program based on specific outcome measure findings. |
| Generic physical therapy home exercise program | Active comparator | Behavioral: Task Specific Physical Therapy Home ProgramGeneralized fitness-based exercise program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Definitive diagnosis of Multiple sclerosis
- Ability to walk for at least 30 seconds unassisted with or without assistive device
- Ability to read, comprehend and sign an informed consent
- Is able to attend a 2 outpatient evaluation sessions 6 weeks apart
- Between the ages of 18 and 75
Key exclusion criteria (3 listed)
- Evidence of recent MS exacerbation
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 Therapy Home ProgramHome exercise program based on specific findings from physical therapy evaluations. | Behavioural | Generic physical therapy home exercise program, Individualized Task Specific Physical Therapy Home Exercise Program |
Primary outcome
6 Minute Walk Test
Time frame: Measured before and after each 4 weeks
Participant walks at best comfortable pace for 6 consecutive minutes; total distance walked and distance per minute is measured.
The Functional Gait Assessment
Time frame: Measured before and after each 4 weeks
A measure of walking balance assessed by participant's performance on specific task.
The Mini Balance Evaluation Systems Test (MBEST)
Time frame: Measured before and after each 4 weeks
Assessment of participant balance during reactive anticipatory, dynamic and sensory aspects of balance tasks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 34343867Ghahfarrokhi MM, Banitalebi E, Negaresh R, Motl RW. Home-Based Exercise Training in Multiple Sclerosis: A Systematic Review with Implications for Future Research. Mult Scler Relat Disord. 2021 Oct;55:103177. doi: 10.1016/j.msard.2021.103177. Epub 2021 Jul 27.
- Background: PubMed 19413920Dalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11.
- Background: PubMed 32310197Ozkul C, Guclu-Gunduz A, Eldemir K, Apaydin Y, Gulsen C, Yazici G, Soke F, Irkec C. Effect of task-oriented circuit training on motor and cognitive performance in patients with multiple sclerosis: A single-blinded randomized controlled trial. NeuroRehabilitation. 2020;46(3):343-353. doi: 10.3233/NRE-203029.
- Background: PubMed 14742602McGuigan C, Hutchinson M. The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure. J Neurol Neurosurg Psychiatry. 2004 Feb;75(2):266-9.
- Background: PubMed 2803071Krupp LB, LaRocca NG, Muir-Nash J, Steinberg AD. The fatigue severity scale. Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol. 1989 Oct;46(10):1121-3. doi: 10.1001/archneur.1989.00520460115022.
- Background: PubMed 27903937Goldman MD, Ward MD, Motl RW, Jones DE, Pula JH, Cadavid D. Identification and validation of clinically meaningful benchmarks in the 12-item Multiple Sclerosis Walking Scale. Mult Scler. 2017 Sep;23(10):1405-1414. doi: 10.1177/1352458516680749. Epub 2016 Dec 7.
- Background: PubMed 16372431Savci S, Inal-Ince D, Arikan H, Guclu-Gunduz A, Cetisli-Korkmaz N, Armutlu K, Karabudak R. Six-minute walk distance as a measure of functional exercise capacity in multiple sclerosis. Disabil Rehabil. 2005 Nov 30;27(22):1365-71. doi: 10.1080/09638280500164479.
- Background: PubMed 32607064Forsberg A, Andreasson M, Nilsagard Y. The Functional Gait Assessment in People with Multiple Sclerosis: Validity and Sensitivity to Change. Int J MS Care. 2017 Mar-Apr;19(2):66-72. doi: 10.7224/1537-2073.2015-061.
- Background: PubMed 31762543Potter K, Bowling R, Kavanagh L, Stone A, Witt B, Wooldridge A. Reliability, Validity, and Responsiveness of the Mini-Balance Evaluation Systems Test in Ambulatory Individuals with Multiple Sclerosis. Physiother Can. 2019 Fall;71(4):327-334. doi: 10.3138/ptc-2018-0071.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available. The specific individual participant data sets are to be shared are, collected IPD, all IPD that underlie results in a publication.
Related trials for Multiple Sclerosis
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
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.
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, United States
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 Home Program in people with Multiple Sclerosis, run by New York Presbyterian Brooklyn Methodist Hospital 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 5 inclusion and 3 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 3 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (time frame: Measured before and after each 4 weeks). The study lists 3 primary outcomes in all. 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 NCT06486116, which also lists 9 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 3 Jul 2024.