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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06001424
Other study ID # P.T.REC/012/001987
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 24, 2018
Est. completion date May 29, 2021

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 29, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
physical therapy
Frenkel's exercises for lower limb, Proprioceptive neuromuscular facilitation for upper limb in the form of rhythmic stabilization
life kinetic exercises
A multimodal training that combines coordinative, cognitive and visual tasks.

Locations

Country Name City State
Egypt Faculty of Physical Therapy Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Lower Extremity Motor Coordination Test (LEMOCOT) test to assess lower limb coordination at baseline
Primary Lower Extremity Motor Coordination Test (LEMOCOT) test to assess lower limb coordination post intervention (after one month)
Secondary Four Square Step Test (FSST) test to assess dynamic balance at baseline
Secondary Four Square Step Test (FSST) test to assess dynamic balance post intervention (after one month)
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