Effectiveness of Task Specific Home Exercise Program

NCT06486116 | Recruiting DMC

• 1 other identifier: 2160034
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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). 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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• 6 Minute Walk Test

  Participant walks at best comfortable pace for 6 consecutive minutes; total distance walked and distance per minute is 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 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 before and after each 4 weeks

Study Arms (2)

Individualized Task Specific Physical Therapy Home Exercise Program

EXPERIMENTAL

Physical Therapy Home Exercise program based on specific outcome measure findings.

Behavioral: Task Specific Physical Therapy Home Program

Generic physical therapy home exercise program

ACTIVE COMPARATOR

Generalized fitness-based exercise program

Behavioral: Task Specific Physical Therapy Home Program

Interventions

Task Specific Physical Therapy Home Program BEHAVIORAL

Home exercise program based on specific findings from physical therapy evaluations.

Generic physical therapy home exercise program; Individualized Task Specific Physical Therapy Home Exercise Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 34343867 BACKGROUND

• Dalgas U, Ingemann-Hansen T, Stenager E. Physical Exercise and MS Recommendations. Int MS J. 2009 Apr;16(1):5-11.

  PMID: 19413920 BACKGROUND

• Ozkul 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.

  PMID: 32310197 BACKGROUND

• McGuigan 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.

  PMID: 14742602 BACKGROUND

• Krupp 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.

  PMID: 2803071 BACKGROUND

• Goldman 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.

  PMID: 27903937 BACKGROUND

• Savci 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.

  PMID: 16372431 BACKGROUND

• Forsberg 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.

  PMID: 32607064 BACKGROUND

• Potter 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.

  PMID: 31762543 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 3, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be shared following publication of our findings in an article in the appropriate peered review journal.
• Access Criteria: Requests for data will be considered on an individual basis by the Principal Investigator.

Locations

US (1)