NCT04448275

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

3 months

First QC Date

June 22, 2020

Last Update Submit

January 5, 2021

Conditions

Keywords

Neurodynamics,Nerve flossing;femoral neuropathy, haemophilia,

Outcome Measures

Primary Outcomes (3)

  • Electromyography Nerve conduction study

    Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device

    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.

    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

    12 weeks

Study Arms (2)

study group

EXPERIMENTAL

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

Other: Neurodynamics Nerve flossingOther: 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

Other: conventional selected exercise program

Interventions

Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of: "slider technique" and the second is the "tensioner technique

study group

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

control groupstudy group

Eligibility Criteria

Age12 Years - 16 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

Giza, El-Sheikh Zayed City Giza 1133 Egypt, Egypt

Location

MeSH Terms

Conditions

Femoral NeuropathyHemophilia A

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lama S Mahmoud, PHD

    lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

First Submitted

June 22, 2020

First Posted

June 25, 2020

Study Start

June 30, 2020

Primary Completion

September 30, 2020

Study Completion

October 30, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations