Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients

Sponsor

Lama Saad El-Din Mahmoud (Other)

Overall Status

Completed

CT.gov ID

NCT04448275

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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?

Condition or Disease	Intervention/Treatment	Phase
Femoral Neuropathy in Haemophilic Patients	Other: Neurodynamics Nerve flossing Other: conventional selected exercise program	N/A

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

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 monthscontrol 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)

Primary Purpose:

Treatment

Official Title:

Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients

Actual Study Start Date :

Jun 30, 2020

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Oct 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve	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 Other: conventional selected exercise program 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	Other: conventional selected exercise program Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise

Arm

Intervention/Treatment

Experimental: study group

received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve

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

Other: conventional selected exercise program

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

Other: conventional selected exercise program

Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise

Outcome Measures

Primary Outcome Measures

Electromyography Nerve conduction study [12 weeks]
Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device
Femoral Nerve Tension Test, for femoral nerve injury [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 16 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 University	Giza	El-Sheikh Zayed City Giza 1133 Egypt	Egypt

Sponsors and Collaborators

Lama Saad El-Din Mahmoud

Investigators

Study Director: Lama S Mahmoud, PHD, lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lama Saad El-Din Mahmoud, Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity, October 6 University

ClinicalTrials.gov Identifier:

NCT04448275

Other Study ID Numbers:

P.T./REC /012/002733

First Posted:

Jun 25, 2020

Last Update Posted:

Jan 6, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lama Saad El-Din Mahmoud, Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity, October 6 University

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Femoral Neuropathy

Study Results

No Results Posted as of Jan 6, 2021