Multiple SclerosisNCT07064239
Effect of Cooling Vest in Multiple Sclerosis Patients
A study testing cooling vest and Aerobic exercises in people with Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- cooling vest and Aerobic exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2025to 8 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cooling Vest on Fatigue and Spatiotemporal Gait Parameters 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).
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- cooling vest, Aerobic exercises
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cooling vestDevice
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 exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: cooling vest; Other: Aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At baseline and re assessed 6 weeks later.
Secondary outcomes (1)
functional capacity
functional capacity assessed using six minute walk test(meters/minutes)
Measured: At baseline and re assessed 6 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start20 May 2025
- Primary completion3 Jul 2025 (estimated)
- Study completion8 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Khalil essa ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064239
- Sponsor's protocol ID
- P.T.Rec/012/005788
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cooling Vest on Fatigue and Spatiotemporal Gait Parameters in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT07064239
- Acronym / sponsor ID
- P.T.Rec/012/005788
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 May 2025 (actual)
- Primary completion
- 3 Jul 2025 (estimated)
- Study completion
- 8 Jul 2025 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A placebo group | Placebo comparator | Other: Aerobic exercisesinclude 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. |
| Group B cooling vest group | Experimental | Device: cooling vest, Other: Aerobic exercisesinclude 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cooling vestCooling 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 | Device | Group B cooling vest group |
| Aerobic exercisesaerobic 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 | Other | Group A placebo group, Group B cooling vest group |
Primary outcome
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.
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)
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)
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)
1 secondary outcome
functional capacity
Time frame: At baseline and re assessed 6 weeks later.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cooling vest and Aerobic exercises in people with Multiple Sclerosis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fatigue (time frame: At baseline and re assessed 6 weeks later.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.