Effect of Cooling Vest in Multiple Sclerosis Patients

NCT07064239 | Active Not Recruiting

• 1 other identifier: P.T.Rec/012/005788
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• fatigue

  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.

  At baseline and re assessed 6 weeks later.

• gait parameter (Gait Speed)

  kinovea software used for assessment: • The unit of measurement for gait speed is meter/second (m/sec)

  At baseline and re assessed 6 weeks later.

• gait parameters: Stride Length and Stride Length

  kinovea software used for assessment: • The unit of measurement for Stride Length and Stride Length is centimeter (cm)

  At baseline and re assessed 6 weeks later.

• gait parameter (Double Support)

  kinovea software used for assessment: • The unit of measurement for Double Support is seconds (sec)

  At baseline and re assessed 6 weeks later.

Secondary Outcomes (1)

• functional capacity

  At baseline and re assessed 6 weeks later.

Study Arms (2)

Group A placebo group

PLACEBO COMPARATOR

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.

Other: Aerobic exercises

Group B cooling vest group

EXPERIMENTAL

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.

Device: cooling vest; Other: Aerobic exercises

Interventions

cooling vest DEVICE

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

Group B cooling vest group

Aerobic exercises OTHER

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

Group A placebo group; Group B cooling vest group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 14, 2025
• Study Start: May 20, 2025
• Primary Completion: July 3, 2025
• Study Completion: July 8, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

EG (1)