Effect of Cooling Vest in Multiple Sclerosis Patients

Not Applicable

Active, not recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT07064239
• Lead Sponsor: Cairo University

Brief Summary

This study is prospective, randomized controlled trail that will be conducted to investigate the effect of cooling therapy on fatigue and gait in patient with multiple sclerosis(MS).

Detailed Description

Thirty patients from both sexes will be enrolled in this study. They will be assigned into two equal groups (study and control groups). Patients will be diagnosed as MS patients based on careful clinical evaluation by the neurologist and magnetic resonance imaging (MRI) of the brain. The patients will be recruited from the faculty of Physical Therapy, Cairo University, and El Kasr El Ainy hospitals.

Study Timeline

• Study Start: 2025-05-20
• Study First Submitted: 2025-06-20
• Status Verified: 2025-07
• Primary Completion: 2025-07-03
• Study Completion: 2025-07-08
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Thirty MS patients of both sexes.
• Age of patients ranges from 20 to 40 years.
• NOT less than 8 months since Symptoms onset.
• The body mass index ranged (BMI) from 20 - 24.5 Kg/m2 .
• The grade of The muscle tone of the affected limbs muscles ranged from 1
• to 2 grade according to Modified Ashower scale of muscle tone
• All the patients are medically stable.
• Patients have intact sensations (deep & superficial).

Exclusion Criteria

• Other neurological and orthopedic impairments in upper or lower limb.
• Having visual and hearing problems.
• Inability to sit independently on a chair.
• Impaired cognition and impaired comprehension and ideomotor apraxia.
• History of endogenous depression or severe psychiatric disorders.
• Severe neglect, and major medical problems or comorbidities that will influence upper or lower extremity usage or cause severe pain.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
fatigue	At baseline and re assessed 6 weeks later.	assessed by Fatigue Severity Scale(FSS): FSS is designed to measure fatigue in a single dimension using the nine items, which represent a single scale. Each FSS item consists of statements that are scored on a seven-point Likert type scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The mean of the nine item scores is used as the FSS score, which ranges from 1 to 7. However, some studies have calculated an FSS score as the sum of all nine items, ranging from 9 to 63.The unit of measurement is points.
gait parameter (Gait Speed)	At baseline and re assessed 6 weeks later.	kinovea software used for assessment: • The unit of measurement for gait speed is meter/second (m/sec)
gait parameters: Stride Length and Stride Length	At baseline and re assessed 6 weeks later.	kinovea software used for assessment: • The unit of measurement for Stride Length and Stride Length is centimeter (cm)
gait parameter (Double Support)	At baseline and re assessed 6 weeks later.	kinovea software used for assessment: • The unit of measurement for Double Support is seconds (sec)

Secondary Outcome Measures

Name	Time	Method
functional capacity	At baseline and re assessed 6 weeks later.	functional capacity assessed using six minute walk test(meters/minutes)

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt