Back to resultsEffect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients
Primary Purpose
Femoral Neuropathy in Haemophilic Patients
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Neurodynamics Nerve flossing
conventional selected exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neuropathy in Haemophilic Patients focused on measuring Neurodynamics,, Nerve flossing;, femoral neuropathy, , haemophilia,
Eligibility Criteria
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.
Sites / Locations
- October 6 University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
study group
control group
Arm Description
received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve
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
Outcomes
Primary Outcome Measures
Electromyography Nerve conduction study
Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04448275
First Posted
June 22, 2020
Last Updated
January 5, 2021
Sponsor
Lama Saad El-Din Mahmoud
1. Study Identification
Unique Protocol Identification Number
NCT04448275
Brief Title
Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients
Official Title
Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lama Saad El-Din Mahmoud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neuropathy in Haemophilic Patients
Keywords
Neurodynamics,, Nerve flossing;, femoral neuropathy, , haemophilia,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve
Arm Title
control group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Neurodynamics Nerve flossing
Intervention Description
Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of:
"slider technique" and the second is the "tensioner technique
Intervention Type
Other
Intervention Name(s)
conventional selected exercise program
Intervention Description
Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise
Primary Outcome Measure Information:
Title
Electromyography Nerve conduction study
Description
Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device
Time Frame
12 weeks
Title
Femoral Nerve Tension Test, for femoral nerve injury
Description
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.
Time Frame
12 weeks
Title
Manual muscle test, Oxford five grades of muscle power assessment
Description
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
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama S Mahmoud, PHD
Organizational Affiliation
lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy
Official's Role
Study Director
Facility Information:
Facility Name
October 6 University
City
Giza
State/Province
El-Sheikh Zayed City Giza 1133 Egypt
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients
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