Balance Targeted Exercises for Individuals With MS

Multiple Sclerosis Clinical Trial

Official title:

The Effect of a Targeted Exercise Program on Balance and Postural Responses in Patients With Multiple Sclerosis (MS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159361
• Other study ID #: 20231151
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Miami
• Contact: James Moore, PhD
• Phone: 5613796461
• Email: jgmoore[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of a postural adjustment, targeted training program on balance ability and postural responses anticipatory postural adjustments (APA) and compensatory postural adjustments (CPA) in individuals with MS

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Must be18 to 70 years of age.

2. Medical diagnosis of MS confirmed by a neurologist.

3. Ability to stand independently without any aid for at least 3 minutes.

4. A Patients determined disease steps (PDDS) score of 5 or lower.

5. Normal or corrected-to-normal vision.

6. English or Spanish speaking.

Exclusion Criteria:

1. MS-related exacerbation or medication change in the past two months.

2. Presence of concurrent neurological or orthopedic disorders.

3. Unable to perform the experimental tasks.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Balance targeted exercises
6-week exercise program, 3 sessions per week (2 sessions in person, 1 session of home exercises. Participants will receive a booklet with information about the home exercises and will receive a text message reminder), each session will last 60 minutes.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in balance ability as measured by the BESTest	The Balance Evaluation Systems Test (BESTest) will be used to measure balance ability. Items are scored from 0 (severe impairment) to 3 (no impairment), with a total score of 108. A higher score suggests better balance ability.	Baseline, 6 weeks (post intervention)
Primary	Change in reaction time	Measure in seconds	Baseline, 6 weeks (post intervention)
Primary	Change in movement velocity	Measure in degree per second	Baseline, 6 weeks (post intervention)
Primary	Change in endpoint excursion percentage	measure of endpoint excursion in a percentage out of a100	Baseline, 6 weeks (post intervention)
Primary	Change in directional control percentage	measure of directional control in a percentage out of a100	Baseline, 6 weeks (post intervention)
Primary	Change in maximum excursion percentage	measure of maximum excursion in a percentage out of a100	Baseline, 6 weeks (post intervention)
Primary	Change in muscle responses latency as measured by MCT	The Motor Control test (MCT) measures the subject's ability to generate a motor response latency to a sudden surface translation in a forward and backward direction at three different magnitudes (small, medium, and large).; Latency: The time-lapse between the perturbation onset and the subject response for each limb. The latency is reported in milliseconds.	Baseline, 6 weeks (post intervention)
Primary	Change in postural muscles responses latency as measured by Electromyography (EMG)	Postural muscles responses onset latency in seconds	Baseline, 6 weeks (post intervention)
Primary	Change in APA as measured by microvolts	Postural muscles APA measured in microvolts	Baseline, 6 weeks (post intervention)
Primary	Change in CPA as measured by microvolts	Postural muscles CPA in microvolts	Baseline, 6 weeks (post intervention)
Secondary	Change in balance confidence as measured by ABC	The Activities Specific Balance Confidence (ABC) scale is a self-report questionnaire of a subject's perceived level of balance confidence. It measures the subject's confidence in performing various ambulatory activities without falling. There are 16 items scored using a scale(0-100) with higher scores indicating more confidence in performing the tasks. A total score is reported by dividing the total ABC score by 16.	Baseline, 6 weeks (post intervention)
Secondary	Change in quality of life as measured by the MSQoL-54	Multiple Sclerosis Quality of Life - 54 (MSQoL-54) is a self-report questionnaire measuring subject perceived of quality of life. In total, it contains 54 items with a total score ranging from 0-100, with higher scores indicating a better quality of life	Baseline, 6 weeks (post intervention)