NCT03954730

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

3 months

First QC Date

May 16, 2019

Last Update Submit

August 8, 2019

Conditions

Keywords

Eccentric trainingActive Release Technique

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Modified Harris Hip score(MHHS)

    Baseline

  • Modified Harris Hip score(MHHS)

    post 6th week

Study Arms (2)

Eccentric Training Group

EXPERIMENTAL

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.

Other: Eccentric Training

Active Release Technique Group

ACTIVE COMPARATOR

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.

Other: Active Release Technique

Interventions

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).

Eccentric Training Group

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).

Active Release Technique Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 40-65 years
  • Patient with stable vitals on 3rd post-operative day
  • Postero-Lateral Hip surgical approach

You may not qualify if:

  • History of prior fracture
  • History of fall
  • Multiple fractures
  • Cognitive impairment (Score ˂26 on Montreal cognitive assessment)
  • Co-morbid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 24453665BACKGROUND
  • 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.

    PMID: 29484358BACKGROUND
  • 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.

    PMID: 29412443BACKGROUND
  • 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.

    PMID: 29902705BACKGROUND

Study Officials

  • Huma Riaz, PHD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sealed envelope method is used to randomly assign participants into two groups. The therapist will know about the treatment but patient is not aware of treatment type.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There will be two treatment groups of participants, One group will be trained on eccentric graded protocol whereas the other will receive active release technique of quadriceps.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 17, 2019

Study Start

March 19, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations