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Effect of Cooling Vest in Multiple Sclerosis Patients

Effect of Cooling Vest on Fatigue and Spatiotemporal Gait Parameters in Multiple Sclerosis Patients

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07064239
Enrollment
30
Registered
2025-07-14
Start date
2025-05-20
Completion date
2025-07-08
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

Cooling vest : It is one of cooling methods proposed to improve exercise performance in MS by reducing one's core and/or skin temperature before taking on physical work

OTHERAerobic exercises

aerobic exercise as any activity that uses large muscle groups, can be maintained continuously and is rhythmic in nature. As the name implies, muscle groups activated by this type of exercise rely on aerobic metabolism to extract energy in the form of adenosine triphosphate (ATP) from amino acids, carbohydrates and fatty acids. Examples of aerobic exercise include cycling, dancing, hiking, jogging/long distance running, swimming and walking

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
fatigueAt 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 LengthAt 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

MeasureTime frameDescription
functional capacityAt baseline and re assessed 6 weeks later.functional capacity assessed using six minute walk test(meters/minutes)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026