Effect of Cooling Vest in Multiple Sclerosis Patients

Cairo University (CU)

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Treatments: Device: cooling vest; Other: Aerobic exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT07064239

P.T.Rec/012/005788

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Group A placebo group

Placebo Comparator group

Description:

include A 15 individuals with relapsing-remitting MS performed 30 minutes of aerobic exercise (upper- and lower-extremity ergometry and treadmill ambulation) without wearing cooling vest, followed by unstructured physical activity. 15 participants completed the intervention and posttest follow-up. quality of life (measured with the Multiple Sclerosis Quality of Life-54; MSQOL-54) were assessed. Participants completed 27.9 minutes of exercise per session, session will done for three sessions of aerobic exercise and Frenkel Coordination Exercises per week for 6 weeks.

Treatment:

Other: Aerobic exercises

Group B cooling vest group

Experimental group

Description:

include A 15 individuals with relapsing-remitting MS performed 30 minutes of aerobic exercise (upper- and lower-extremity ergometry and treadmill ambulation) with wearing cooling vest, followed by unstructured physical activity. Eight participants completed the intervention and posttest follow-up. quality of life (measured with the Multiple Sclerosis Quality of Life-54; MSQOL-54) were assessed. Participants completed 27.9 minutes of exercise per session, session will done for three sessions of aerobic exercise and Frenkel Coordination Exercises per week for 6 weeks.

Treatment:

Other: Aerobic exercises

Device: cooling vest