Effectiveness of Task Specific Home Exercise Program

June 26, 2024 updated by: Karen Blitz-Shabbir, New York Presbyterian Brooklyn Methodist Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • New York Presbyterian Brooklyn Methodist Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karen Blitz-Shabbir, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized Task Specific Physical Therapy Home Exercise Program
Physical Therapy Home Exercise program based on specific outcome measure findings.
Behavioral: Task Specific Physical Therapy Home Program
Home exercise program based on specific findings from physical therapy evaluations.
Active Comparator: Generic physical therapy home exercise program
Generalized fitness-based exercise program
Behavioral: Task Specific Physical Therapy Home Program
Home exercise program based on specific findings from physical therapy evaluations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured before and after each 4 weeks
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.
Measured before and after each 4 weeks
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.
Measured before and after each 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Presbyterian Brooklyn Methodist Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2160034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be shared following publication of our findings in an article in the appropriate peered review journal.

IPD Sharing Access Criteria

Requests for data will be considered on an individual basis by the Principal Investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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