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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04448275
Other study ID # P.T./REC /012/002733
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 30, 2020
Est. completion date October 30, 2020

Study information

Verified date January 2021
Source October 6 University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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?


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender Male
Age group 12 Years to 16 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Femoral Neuropathy
  • Femoral Neuropathy in Haemophilic Patients
  • Peripheral Nervous System Diseases

Intervention

Other:
Neurodynamics Nerve flossing
Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of: "slider technique" and the second is the "tensioner technique
conventional selected exercise program
Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise

Locations

Country Name City State
Egypt October 6 University Giza El-Sheikh Zayed City Giza 1133 Egypt

Sponsors (1)

Lead Sponsor Collaborator
Lama Saad El-Din Mahmoud

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electromyography Nerve conduction study Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device 12 weeks
Primary 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.
12 weeks
Primary 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
12 weeks