- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06001424
Effect of Life Kinetik Training on Lower Limb Coordination in Ataxic Patients
August 18, 2023 updated by: heba ahmed khalifa, Cairo University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
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
-
-
-
Giza, Egypt, 11432
- Faculty of Physical Therapy
-
-
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
Accepts Healthy Volunteers
No
Description
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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
will receive physical therapy program of in addition to life kinetik training.
|
Frenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization
A multimodal training that combines coordinative, cognitive and visual tasks.
|
|
Active Comparator: control
will receive physical therapy program
|
Frenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower Extremity Motor Coordination Test (LEMOCOT)
Time Frame: at baseline
|
test to assess lower limb coordination
|
at baseline
|
|
Lower Extremity Motor Coordination Test (LEMOCOT)
Time Frame: post intervention (after one month)
|
test to assess lower limb coordination
|
post intervention (after one month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Four Square Step Test (FSST)
Time Frame: at baseline
|
test to assess dynamic balance
|
at baseline
|
|
Four Square Step Test (FSST)
Time Frame: post intervention (after one month)
|
test to assess dynamic balance
|
post intervention (after one month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Moshera H Darwish, Prf. Dr, Professor of Physical therapy for Neurology
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.
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 24, 2018
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
May 29, 2021
Study Registration Dates
First Submitted
January 17, 2021
First Submitted That Met QC Criteria
August 18, 2023
First Posted (Actual)
August 21, 2023
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 18, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/001987
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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