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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03954730
Other study ID # RiphahIU Qurat-ul-ain Saeed
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 19, 2019
Est. completion date June 30, 2019

Study information

Verified date August 2019
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare the effects of Eccentric training and Strength training with priory applied Active Release Technique on Quadriceps muscle in post operative patients of Dynamic Hip screw. Participants would be equally divided into two groups each receiving specific type of protocol besides standard post operative protocol of Dynamic Hip screw


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Eccentric Training
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).
Active Release Technique
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).

Locations

Country Name City State
Pakistan Fauji Foundation Hospital Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric Pain Rating Scale (NPRS) 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. Baseline
Primary Numeric Pain Rating Scale (NPRS) 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. post 6th week
Primary Knee Range of Motion (ROM) 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. Baseline
Primary Knee Range of Motion (ROM) 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. post 6th week
Secondary Modified Harris Hip score(MHHS) 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). Baseline
Secondary Modified Harris Hip score(MHHS) 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). post 6th week
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