Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07064239

Effect of Cooling Vest in Multiple Sclerosis Patients

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. fatigue

    Time frame: 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.

  2. gait parameter (Gait Speed)

    Time frame: 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)

  3. gait parameters: Stride Length and Stride Length

    Time frame: 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)

  4. gait parameter (Double Support)

    Time frame: At baseline and re assessed 6 weeks later.

    kinovea software used for assessment:

    • The unit of measurement for Double Support is seconds (sec)

Secondary outcomes

  1. functional capacity

    Time frame: At baseline and re assessed 6 weeks later.

    functional capacity assessed using six minute walk test(meters/minutes)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.