Clinical trial NCT06159361: Balance Targeted Exercises for Individuals With MS
Official title: The Effect of a Targeted Exercise Program on Balance and Postural Responses in Patients With Multiple Sclerosis (MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Detailed description: All participants participated in individual training program aimed at improving balance ability and postural adjustments. The training program and individual activities were based on previously published programs and motor learning principles, and consists of 18, 1-hour training sessions over six weeks (3 sessions/week). Training occurred in person 2 days a week (in person training) and at home (home exercise program) 1 day a week, for a total of 3 sessions per week. The duration of training sessions were 60 minutes per session for a total of 1,140 minutes of training. The exercise room temperature was centrally regulated (23.3 degrees C).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in balance ability as measured by the BESTest
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in reaction time
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in movement velocity
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in endpoint excursion percentage
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in directional control percentage
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in maximum excursion percentage
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in muscle responses latency as measured by MCT
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in postural muscles responses latency as measured by Electromyography (EMG)
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in APA as measured by microvolts
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in CPA as measured by microvolts
timeFrame: Baseline, 6 weeks (post intervention)
Secondary outcomes:
measure: Change in balance confidence as measured by ABC
timeFrame: Baseline, 6 weeks (post intervention)
measure: Change in quality of life as measured by the MSQoL-54
timeFrame: Baseline, 6 weeks (post intervention)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: James Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References: