Femoral Neuropathy in Haemophilic PatientsNCT04448275
Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients
A study testing Neurodynamics Nerve flossing and conventional selected exercise program in people with Femoral Neuropathy in Haemophilic Patients, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
Trial summary
To investigate the effect of Neurodynamics Nerve flossing on femoral neuropathy in patients with haemophilia Background: heamophilia is one of the serious chronic disorders in children and adolescents which results in less physical activities and restlessness hours than their peer. Read more about this study
- Who is it for?
- Ages 12 to 16 years, men only
- Conditions the study is for
- Femoral Neuropathy in Haemophilic Patients
- What is being tested?
- Neurodynamics Nerve flossing and conventional selected exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2020to 30 Oct 2020
- 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 12 to 16 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- hemophilia A or B, all the patients
- positive femoral nerve tension test
- the Manual muscle test for iliopsoas and quadriceps muscles in all patients not less than grade 2 according to the oxford scale
- the age ranging from (12:16) years
- all the participants will be able to communicate verbally ,obey commands and instructions and co-operate with testing and training protocols
Who cannot join
- any participants have auditory, visual and sever cardiac disorders
- Patients who have mild degree of hemophilia
- Patients who have joint, muscle bleeding or pain in the lower limb in the preceding 3 weeks
- patients with any other neurological disorders or musculoskeletal disorders or deformities of the lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of Neurodynamics Nerve flossing on femoral neuropathy in patients with haemophilia
Background: heamophilia is one of the serious chronic disorders in children and adolescents which results in less physical activities and restlessness hours than their peer.
HYPOTHESES:
This study will hypnotize that:
Neurodynamics Nerve flossing will have a significant effect on femoral neuropathy in patients with haemophilia
RESEARCH QUESTION:
will the Neurodynamics Nerve flossing has an effect on femoral neuropathy in patients with haemophilia?
Read the detailed description
Haemophilic patients with Femoral Neuropathy will be randomly divided in two equal groups control group which will receive conventional selected exercise program and study group will receive the same exercise training program in addition to Neurodynamics Nerve flossing three times per week for three successive months.
The Evaluation will done pre and post interventions included:
femoral nerve motor conduction velocity, muscle test For Iliopsoas and Quadriceps muscles and Pain visual analogue scale.
- Being tested
- Neurodynamics Nerve flossing, conventional selected exercise program
- Keywords
- Neurodynamics,, Nerve flossing;, femoral neuropathy, , haemophilia,
- Medical subject headings
- Femoral Neuropathy, Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodynamics Nerve flossingOther
Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of:
"slider technique" and the second is the "tensioner technique
conventional selected exercise programOther
Ultrasound therapy The flexibility exercises for iliopsoas \& quadriceps The iliopsoas \& quadriceps muscles strength exercise
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve Receives: Other: Neurodynamics Nerve flossing; Other: conventional selected exercise program |
| control group | Experimental | received conventional selected exercise program in form of: Ultrasound therapy The flexibility exercises for iliopsoas \& quadriceps in heamophilic patient The iliopsoas \& quadriceps muscles strength exercise Receives: Other: conventional selected exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography Nerve conduction study
Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device
Measured: 12 weeks
Femoral Nerve Tension Test, for femoral nerve injury
Femoral Nerve Tension Test is a neural tension test used to stress the femoral nerve
A positive test was be reproduction of the patient's symptoms as burning discomfort in the groin or anterior thigh occurred if there was femoral nerve involvement.
Measured: 12 weeks
Manual muscle test, Oxford five grades of muscle power assessment
The group Manual muscle test was used for testing the strength of iliopsoas and quadriceps muscles, according to the Oxford Scale as the Muscle strength is often rated on a scale of 0/5 as follow:
(0/5) no contraction of muscle, (1/5) muscle flicker contraction, but no movement (2/5) movement possible, but not against gravity (test the joint in its horizontal plane), (3/5) movement possible against gravity, but not against resistance by the therapist, (4/5) movement possible against some resistance by the examiner and (5/5) normal strength
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start30 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neuropathy in Haemophilic PatientsStudies of the same condition, open and under way.
- 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
- Model description
- control group which received conventional selected exercise program in form of Ultrasound therapy The flexibility exercises for iliopsoas \& quadriceps The iliopsoas \& quadriceps muscles strength exercise and study group received the same exercise training program in addition to Neurodynamics Nerve flossing three times per week for three successive months
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lama Saad El-Din Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lama Saad El-Din Mahmoud, October 6 University
- Investigators
- Lama S Mahmoud, PHD, Study director, lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448275
- Sponsor's protocol ID
- P.T./REC /012/002733
- Status last verified
- Jan 2021
- First submitted
- 22 Jun 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients
- ClinicalTrials.gov ID
- NCT04448275
- Acronym / sponsor ID
- P.T./REC /012/002733
- Keywords
- Neurodynamics,, Nerve flossing;, femoral neuropathy, , haemophilia,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Lama Saad El-Din MahmoudUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 25 Jun 2020 (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.
To investigate the effect of Neurodynamics Nerve flossing on femoral neuropathy in patients with haemophilia
Background: heamophilia is one of the serious chronic disorders in children and adolescents which results in less physical activities and restlessness hours than their peer.
HYPOTHESES:
This study will hypnotize that:
Neurodynamics Nerve flossing will have a significant effect on femoral neuropathy in patients with haemophilia
RESEARCH QUESTION:
will the Neurodynamics Nerve flossing has an effect on femoral neuropathy in patients with haemophilia?
Detailed description
Haemophilic patients with Femoral Neuropathy will be randomly divided in two equal groups control group which will receive conventional selected exercise program and study group will receive the same exercise training program in addition to Neurodynamics Nerve flossing three times per week for three successive months.
The Evaluation will done pre and post interventions included:
femoral nerve motor conduction velocity, muscle test For Iliopsoas and Quadriceps muscles and Pain visual analogue scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control group which received conventional selected exercise program in form of Ultrasound therapy The flexibility exercises for iliopsoas \& quadriceps The iliopsoas \& quadriceps muscles strength exercise and study group received the same exercise training program in addition to Neurodynamics Nerve flossing three times per week for three successive months
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Other: Neurodynamics Nerve flossing, Other: conventional selected exercise programreceived conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve |
| control group | Experimental | Other: conventional selected exercise programreceived conventional selected exercise program in form of: Ultrasound therapy The flexibility exercises for iliopsoas \& quadriceps in heamophilic patient The iliopsoas \& quadriceps muscles strength exercise |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- hemophilia A or B, all the patients
- positive femoral nerve tension test
- the Manual muscle test for iliopsoas and quadriceps muscles in all patients not less than grade 2 according to the oxford scale
- the age ranging from (12:16) years
- all the participants will be able to communicate verbally ,obey commands and instructions and co-operate with testing and training protocols
Key exclusion criteria (4 listed)
- any participants have auditory, visual and sever cardiac disorders
- Patients who have mild degree of hemophilia
- Patients who have joint, muscle bleeding or pain in the lower limb in the preceding 3 weeks
- patients with any other neurological disorders or musculoskeletal disorders or deformities of the lower limb.
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 |
|---|---|---|
| Neurodynamics Nerve flossingNeurodynamics Nerve flossing for femoral nerve that includes two techniques inform of: "slider technique" and the second is the "tensioner technique | Other | study group |
| conventional selected exercise programUltrasound therapy The flexibility exercises for iliopsoas \& quadriceps The iliopsoas \& quadriceps muscles strength exercise | Other | control group, study group |
Primary outcome
Electromyography Nerve conduction study
Time frame: 12 weeks
Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device
Femoral Nerve Tension Test, for femoral nerve injury
Time frame: 12 weeks
Femoral Nerve Tension Test is a neural tension test used to stress the femoral nerve A positive test was be reproduction of the patient's symptoms as burning discomfort in the groin or anterior thigh occurred if there was femoral nerve involvement.
Manual muscle test, Oxford five grades of muscle power assessment
Time frame: 12 weeks
The group Manual muscle test was used for testing the strength of iliopsoas and quadriceps muscles, according to the Oxford Scale as the Muscle strength is often rated on a scale of 0/5 as follow: (0/5) no contraction of muscle, (1/5) muscle flicker contraction, but no movement (2/5) movement possible, but not against gravity (test the joint in its horizontal plane), (3/5) movement possible against gravity, but not against resistance by the therapist, (4/5) movement possible against some resistance by the examiner and (5/5) normal strength
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Individual participant dataSharing planned: No
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.
Lama S Mahmoud, PHD study director
lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodynamics Nerve flossing and conventional selected exercise program in people with Femoral Neuropathy in Haemophilic Patients, run by Lama Saad El-Din Mahmoud 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 4 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: finished, as of the sponsor's last update on 6 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Electromyography Nerve conduction study (time frame: 12 weeks). The study lists 3 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 6 Jan 2021.