Back to resultsEffect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients
Primary Purpose
Multiple Sclerosis, Ataxia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
physical therapy
life kinetic exercises
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, ataxia, coordination, life kinetic exercises
Eligibility Criteria
Inclusion Criteria: MS from both sexes Patients' age will be ranged from 20 to 45 years Expanded disability scale (EDSS) score ranging from "two" to "four" Exclusion Criteria: Patients with Ataxia caused by other cause rather than MS Patients with other neurological disease or orthopedic deformities may affect movement Patients with cardiovascular and pulmonary diseases that make exercise unsafe Patients with cognitive impairment or psychiatric disorders
Sites / Locations
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
study group
control
Arm Description
will receive physical therapy program of in addition to life kinetik training.
will receive physical therapy program
Outcomes
Primary Outcome Measures
Lower Extremity Motor Coordination Test (LEMOCOT)
test to assess lower limb coordination
Lower Extremity Motor Coordination Test (LEMOCOT)
test to assess lower limb coordination
Secondary Outcome Measures
Four Square Step Test (FSST)
test to assess dynamic balance
Four Square Step Test (FSST)
test to assess dynamic balance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06001424
Brief Title
Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients
Official Title
Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 24, 2018 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
May 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Coordination is essential for the performance of most daily motor activities. Coordination problems are common in MS patients. One of the most commonly reported symptoms is dysmetria (limb ataxia). Ataxia is thought to occur in about 80% of MS patients. It leads to limitations in daily life activities. Aim of Study: to investigate the effect of life kinetik training on lower limb coordination in MS patients with ataxia.
Detailed Description
Methods: Thirty remitting relapsing Multiple Sclerosis (RRMS) patients from both sexes with ataxic symptoms, will be recruited from multiple sclerosis specialized clinic in the Neurology department, Faculty of Medicine, Cairo University with EDSS score will be ranged from 2 to 4 and SARA score will be ranged from 1 to 10. Lower Extremity Motor Coordination Test (LEMOCOT) will be used to assess lower limb motor coordination. They will be randomly assigned into two equal groups; control group (GI) will receive selected physical therapy program and study group (GII) will receive same program of (GI) in addition to life kinetik training.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Ataxia
Keywords
Multiple Sclerosis, ataxia, coordination, life kinetic exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trail
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
will receive physical therapy program of in addition to life kinetik training.
Arm Title
control
Arm Type
Active Comparator
Arm Description
will receive physical therapy program
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
Frenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization
Intervention Type
Other
Intervention Name(s)
life kinetic exercises
Intervention Description
A multimodal training that combines coordinative, cognitive and visual tasks.
Primary Outcome Measure Information:
Title
Lower Extremity Motor Coordination Test (LEMOCOT)
Description
test to assess lower limb coordination
Time Frame
at baseline
Title
Lower Extremity Motor Coordination Test (LEMOCOT)
Description
test to assess lower limb coordination
Time Frame
post intervention (after one month)
Secondary Outcome Measure Information:
Title
Four Square Step Test (FSST)
Description
test to assess dynamic balance
Time Frame
at baseline
Title
Four Square Step Test (FSST)
Description
test to assess dynamic balance
Time Frame
post intervention (after one month)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
MS from both sexes
Patients' age will be ranged from 20 to 45 years
Expanded disability scale (EDSS) score ranging from "two" to "four"
Exclusion Criteria:
Patients with Ataxia caused by other cause rather than MS
Patients with other neurological disease or orthopedic deformities may affect movement
Patients with cardiovascular and pulmonary diseases that make exercise unsafe
Patients with cognitive impairment or psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshera H Darwish, Prf. Dr
Organizational Affiliation
Professor of Physical therapy for Neurology
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
11432
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34931569
Citation
Edwards EM, Fritz NE, Therrien AS. Cerebellar Dysfunction in Multiple Sclerosis: Considerations for Research and Rehabilitation Therapy. Neurorehabil Neural Repair. 2022 Feb;36(2):103-106. doi: 10.1177/15459683211065442. Epub 2021 Dec 21.
Results Reference
background
Learn more about this trial
Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients
We'll reach out to this number within 24 hrs