- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04448275
Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Sheikh Zayed City Giza 1133 Egypt
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Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt
- October 6 University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study group
received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve
|
Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of: "slider technique" and the second is the "tensioner technique
Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise
|
|
Experimental: control group
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
|
Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electromyography Nerve conduction study
Time Frame: 12 weeks
|
Femoral Nerve motor conduction velocity (m/sec.)
, via the Neuropack S1 MEB9004 EMG device
|
12 weeks
|
|
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. |
12 weeks
|
|
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 |
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Lama S Mahmoud, PHD, lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T./REC /012/002733
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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