MSNCT06143930
Blood Flow Restriction Training in Multiple Sclerosis
A study testing strengthening ex with BFR training and strengthening ex in people with MS, run by Cairo University at 1 site in Egypt.
Trial summary
Traditional physical therapy resisted training for people with MS have been shown to be beneficial; however, their usefulness has been limited by fatigue. The effect of blood flow restriction on strength and other measures of physical function was demonstrated in healthy populations and those with chronic disease. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- MS
- What is being tested?
- strengthening ex with BFR training and strengthening ex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were diagnosed with MS by a neurologist according to McDonald's criteria 2010
- Expanded Disability Status Scale (EDSS) scores ranging from 2.5 to 5.5 .
- Patient able to walk 100 meters or more.
- No change within MS specific medication three months from the study.
- Last Ms Attack from more than two months.
Who cannot join
- Multiple sclerosis patients with other neurological or orthopedic problems.
- Multiple sclerosis patients with systemic problems (cardiovascular or pulmonary diseases…).
- Patients with cognitive impairment.
- Pregnant female patients.
- Patients in acute relapse stage.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (Effect of Blood Flow Restriction Training on Muscle Strength and Gait Performance in Multiple Sclerosis Patients).
Traditional physical therapy resisted training for people with MS have been shown to be beneficial; however, their usefulness has been limited by fatigue. The effect of blood flow restriction on strength and other measures of physical function was demonstrated in healthy populations and those with chronic disease. This study may add missing information to the existing literature and suggests directions for research on the effectiveness of BFR training on individuals with relapsing and remitting MS.
Read the detailed description
Multiple sclerosis patients are characterized by impaired functional capacity which is related to reduce muscle strength affecting predominantly the lower extremity.
Resistance training (RT) has proven to be one of the interventions in MS patients showing a consistent and positive effect on muscle strength and on parameters directly related to lower extremity physical function (eg, walking performance and stair negotiation).
Training with blood flow restriction (BFR), is an increasingly common clinical intervention among physical therapists over the past decade and consistent with the evidence. It has been investigated in people with neurological disorders including stroke and incomplete Spinal Cord Injuries. Research is limited on the use of BFR for individuals with MS.
- Conditions
- MS
- Being tested
- strengthening ex with BFR training, strengthening ex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
strengthening ex with BFR trainingOther
Therapeutic strengthening training with blood flow restriction of trained limb.
strengthening exOther
Therapeutic strengthening training program for lower extremities.
| Study group | Role | What they receive |
|---|---|---|
| The control group (A) will receive therapeutic strengthening training program for lower extremities. | Active comparator | low intensity strengthening exercise program Receives: Other: strengthening ex |
| The study group (B) will receive strengthening training with blood flow restriction | Active comparator | the same selected low intensity resisted exercise program as group (A) with blood flow restriction Receives: Other: strengthening ex with BFR training |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
measure maximal torque production at a specified velocity of limb movement. measure torque of hip flexors , extensors , knee flexors and extensors
Measured: one week after the end of treatment
Secondary outcomes (1)
gait performance by Two-dimensional (2D) Motion Analysis system
kinematic analysis of gait (step length , stride length)
Measured: one week after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jul 2023
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSStudies 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
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habiba Zienhom Soubhy Mohamed, Cairo University
- Investigators
- Habiba Zienhom, Principal investigator, Cairo UniversityDr.Moshera Hassan Darwish, professor, Study director, professor of physical therapy,aculty of Physical therapy ,Cairo universityDr Mohamed Soliman Al-Tamawy, professor, Study director, professor of Neurology, Faculty of Medicine,Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143930
- Sponsor's protocol ID
- BFR in MS
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Effect of Blood Flow Restriction Training on Muscle Strength and Gait Performance in Multiple Sclerosis Patients).
- ClinicalTrials.gov ID
- NCT06143930
- Acronym / sponsor ID
- BFR in MS
- Conditions
- MS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 22 Nov 2023 (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.
Traditional physical therapy resisted training for people with MS have been shown to be beneficial; however, their usefulness has been limited by fatigue. The effect of blood flow restriction on strength and other measures of physical function was demonstrated in healthy populations and those with chronic disease. This study may add missing information to the existing literature and suggests directions for research on the effectiveness of BFR training on individuals with relapsing and remitting MS.
Detailed description
Multiple sclerosis patients are characterized by impaired functional capacity which is related to reduce muscle strength affecting predominantly the lower extremity.
Resistance training (RT) has proven to be one of the interventions in MS patients showing a consistent and positive effect on muscle strength and on parameters directly related to lower extremity physical function (eg, walking performance and stair negotiation).
Training with blood flow restriction (BFR), is an increasingly common clinical intervention among physical therapists over the past decade and consistent with the evidence. It has been investigated in people with neurological disorders including stroke and incomplete Spinal Cord Injuries. Research is limited on the use of BFR for individuals with MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group (A) will receive therapeutic strengthening training program for lower extremities. | Active comparator | Other: strengthening exlow intensity strengthening exercise program |
| The study group (B) will receive strengthening training with blood flow restriction | Active comparator | Other: strengthening ex with BFR trainingthe same selected low intensity resisted exercise program as group (A) with blood flow restriction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients were diagnosed with MS by a neurologist according to McDonald's criteria 2010
- Expanded Disability Status Scale (EDSS) scores ranging from 2.5 to 5.5 .
- Patient able to walk 100 meters or more.
- No change within MS specific medication three months from the study.
- Last Ms Attack from more than two months.
Key exclusion criteria (6 listed)
- Multiple sclerosis patients with other neurological or orthopedic problems.
- Multiple sclerosis patients with systemic problems (cardiovascular or pulmonary diseases…).
- Patients with cognitive impairment.
- Pregnant female patients.
- Patients in acute relapse stage.
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 |
|---|---|---|
| strengthening ex with BFR trainingTherapeutic strengthening training with blood flow restriction of trained limb. | Other | The study group (B) will receive strengthening training with blood flow restriction |
| strengthening exTherapeutic strengthening training program for lower extremities. | Other | The control group (A) will receive therapeutic strengthening training program for lower extremities. |
Primary outcome
muscle strength
Time frame: one week after the end of treatment
measure maximal torque production at a specified velocity of limb movement. measure torque of hip flexors , extensors , knee flexors and extensors
1 secondary outcome
gait performance by Two-dimensional (2D) Motion Analysis system
Time frame: one week after the end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for MS
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
RecruitingPhase 2
A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)
Primary Progressive Multiple Sclerosis, Primary Progressive MS
RecruitingObservational study
A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
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.
Habiba Zienhom principal investigator
Cairo University
Dr.Moshera Hassan Darwish, professor study director
professor of physical therapy,aculty of Physical therapy ,Cairo university
Dr Mohamed Soliman Al-Tamawy, professor study director
professor of Neurology, Faculty of Medicine,Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing strengthening ex with BFR training and strengthening ex in people with MS, 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 5 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Habiba Zienhom (01061209505 ext. 002, Habiba_future@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: one week after the end of treatment). 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 22 Nov 2023.