- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03954730
Eccentric Training Versus Active Release Technique On Quadriceps In Patients With Dynamic Hip Screw
Comparison Of Eccentric Training And Active Release Technique On Quadriceps Muscle In Patients With Dynamic Hip Screw
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is Randomized Control Trial, being conducted at Fauji Foundation Hospital Rawalpindi .This study will compare the effects of two techniques addressing the contractile as well as non-contractile element of Quadriceps in early phase of Rehabilitation.
Sample size of 18 was calculated using software Epitool with 95% confidence interval and 80% power. Individuals of selected population will be randomly allocated as 9 in Eccentric group and 9 in Active Release Technique group by sealed enveloped method.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Fauji Foundation Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 40-65 years
- Patient with stable vitals on 3rd post-operative day
- Postero-Lateral Hip surgical approach
Exclusion Criteria:
- History of prior fracture
- History of fall
- Multiple fractures
- Cognitive impairment (Score ˂26 on Montreal cognitive assessment)
- Co-morbid disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Eccentric Training Group
Eccentric training will be performed for quadriceps muscle along with strengthening protocol taken from Clinical Guidelines of NHS for post operative Dynamic Hip Screw rehabilitation.
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First session will be performed 24 hours after pre-training tests i.e. on 4th post- operative day and subsequent sessions will be performed with lapse of 48 hours.
During pre-testing, weight for the eccentric training will be determined using Standardized Brzycki formulas for lower limb.
Participants will perform one set of 10 repetitions with selected weight.
Intensity will be increased every week by decreasing the time of performance.
Volume will be increased by increasing one set after two weeks.
Eccentric training will be performed in sitting position on dynamic constant external resistance equipment.After session, patient will perform strengthening of quadriceps muscle as per clinical practice guidelines of National Health Service (UK).
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Active Comparator: Active Release Technique Group
Active release technique will be performed for quadriceps muscle along with strengthening protocol taken from Clinical Guidelines of NHS for post operative Dynamic Hip Screw rehabilitation.
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Isometric Quadriceps' contractions against therapist's resistance lasting for 10 seconds will be performed by the patient in inner range of knee extension and after relaxing; actively perform maximum full knee flexion.
Patient will perform extension at knee joint again; when reaches the innermost range, therapist will apply pressure on deep fascia either through knuckles/fingers or forearm in the direction towards the hip joint and patient is asked to perform knee flexion simultaneously.
The procedure is applied onto vastus lateralis, rectus femoris and vastus intermedialis thrice in a session.
After session, patient will perform strengthening of quadriceps muscle as per clinical practice guidelines of National Health Service (UK).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline
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Numeric Pain Rating Scale (NPRS) is used to assess pain.
It scores ranges from 0-10, 0 means No pain and 10 means Severe pain.
Patient will be asked to verbally report the pain score.
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Baseline
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Knee Range of Motion (ROM)
Time Frame: Baseline
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To assess Knee range of motion (ROM), Goniometer will be use to measure knee range of motion in flexion & extension.
Participants will be seated upright and asked to actively move their knee in each direction.
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Baseline
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Numeric Pain Rating Scale (NPRS)
Time Frame: post 6th week
|
Numeric Pain Rating Scale (NPRS) is used to assess pain.
It scores ranges from 0-10, 0 means No pain and 10 means Severe pain.
Patient will be asked to verbally report the pain score.
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post 6th week
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Knee Range of Motion (ROM)
Time Frame: post 6th week
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To assess Knee range of motion (ROM), Goniometer will be use to measure knee range of motion in flexion & extension.
Participants will be seated upright and asked to actively move their knee in each direction.
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post 6th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Harris Hip score(MHHS)
Time Frame: Baseline
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The modified Harris hip score (MHHS) is used to assess functional outcomes of hip joint.
It is scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain).
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Baseline
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Modified Harris Hip score(MHHS)
Time Frame: post 6th week
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The modified Harris hip score (MHHS) is used to assess functional outcomes of hip joint.
It is scored from 0 (worst functional outcome and maximum pain) to 100 points (best functional outcome and least pain).
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post 6th week
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Amjad M, Akram R, Zaman AU, Ahmad I, Aziz A. Frequency and Causes of Failure of Dynamic Hip Screw Fixation for Interochanteric Fracture. PAKISTAN JOURNAL OF MEDICAL & HEALTH SCIENCES. 2016;10(3):734-40.
- Mue D, Salihu M, Awonusi F. Clinical Outcome Following Treatment Of Pertrochanteric Fractures With Dynamic Hip Screw In A Nigerian Rehabilitation Hospital. Journal of Dental and Medical Sciences. 2014;13(10):56-62.
- Carneiro MB, Alves DP, Mercadante MT. Physical therapy in the postoperative of proximal femur fracture in elderly. Literature review. Acta Ortop Bras. 2013 May;21(3):175-8. doi: 10.1590/S1413-78522013000300010.
- Briggs RA, Houck JR, LaStayo PC, Fritz JM, Drummond MJ, Marcus RL. High-Intensity Multimodal Resistance Training Improves Muscle Function, Symmetry during a Sit-to-Stand Task, and Physical Function Following Hip Fracture. J Nutr Health Aging. 2018;22(3):431-438. doi: 10.1007/s12603-017-0977-1.
- Briggs RA, Houck JR, Drummond MJ, Fritz JM, LaStayo PC, Marcus RL. Muscle Quality Improves with Extended High-Intensity Resistance Training after Hip Fracture. J Frailty Aging. 2018;7(1):51-56. doi: 10.14283/jfa.2017.31.
- Hedayatpour N, Izanloo Z, Falla D. The effect of eccentric exercise and delayed onset muscle soreness on the homologous muscle of the contralateral limb. J Electromyogr Kinesiol. 2018 Aug;41:154-159. doi: 10.1016/j.jelekin.2018.06.003. Epub 2018 Jun 6.
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
Other Study ID Numbers
- RiphahIU Qurat-ul-ain Saeed
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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