NCT04588753

Brief Summary

The aim of this study is to examine the effect of two techniques on hamstrings flexibility in trans-tibial amputees. Reduced flexibility can cause insufficiency at the workplace. Increasing flexibility is to decrease risk of injury, enhances performance and incorporate rehabilitation programs . Further studies are still needed in order to enhance patient rehabilitation protocol and anticipate the prosthetic process. Evidence based Physical therapy could be considered a valid support improving knee contractures in patients with trans-tibial amputation.This research provide an important addition to the evidence-based treatment intervention of physical therapy in amputees rehabilitation as no comparative study between Active Isolated Stretch and Post Facilitation Stretch on hamstring flexibility is done in trans-tibial Amputees.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

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

Study Start

First participant enrolled

December 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

October 9, 2020

Last Update Submit

December 21, 2020

Conditions

Keywords

Trans-tibial AmputeesIsolated StretchPost Facilitation Stretch

Outcome Measures

Primary Outcomes (1)

  • Active Knee Extension Test (AKE)

    used to measure hamstring flexibility. The subject be asked to lie in supine position with the non-tested limb and the pelvis will be strapped to the plinth for stabilization. The tested leg will be positioned in 90 degrees of hip flexion and the knee flexed. Hip flexion will be maintained through the use of a crossbar to maintain the proper position of hip and thigh. A full circle universal goniometer will be used to measure the angle of knee ROM. The fulcrum of the goniometer will be centered over the lateral condyle of the femur with the fixed arm secured along the femur using the greater trochanter as a reference. The movable arm will be aligned with the lower leg using the lateral malleolus as a reference. Subject will be asked to actively extend the tested knee as far as possible until a mild stretch sensation is felt. The procedure will be repeated 3 times and the average will be taken for analysis. Amputees having short hamstring (\>15- 30 degrees loss of knee extension)

    2 weeks

Study Arms (2)

Active Isolated Stretch

ACTIVE COMPARATOR

active isolated stretching, strengthening exercises

Other: active isolated stretch

Post Facilitation Stretch

ACTIVE COMPARATOR

Post Facilitation Stretching, strengthening exercises

Other: Post Facilitation Stretch

Interventions

Active Isolated Stretch (AIS); * The shortened hamstring muscle will be isolated. * The hamstring will be stretched. * This Stretches will be Repeated eight to 10 times. * Stretch will be hold for no more than two seconds. * Exhale on the stretch; inhale on the release. Other amputees training exercises; * weight-shifting * Dynamic balancing activities * Stool stepping * Braiding * Gait exercises * Climbing/descending the stairs

Active Isolated Stretch

Participants of this group will receive Post Facilitation Stretch (PFS); * The shortened hamstring muscle will be placed between a fully stretched and a fully relaxed state. * The patient will be asked to contract the hamstring using a maximum degree of effort for 5-10 seconds while the therapist will resists thepatients force. * The patient will be then asked to relax and release the effort, whereas the therapist will apply a rapid stretch to a new barrier and is held for 10 seconds. * The patient relaxes for approximately 20 seconds and the procedure will be repeated to five times (8) (18). 2\. Other amputees training exercises; * weight-shifting * Dynamic balancing activities * Stool stepping * Braiding * Gait exercises * Climbing/descending the stairs

Post Facilitation Stretch

Eligibility Criteria

Age15 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Unilateral Trans-tibial amputees.
  • Amputees having short hamstring (\>15- 30 degrees loss of knee extension)
  • Patients with traumatic cause of amputation.
  • Patients that are mentaly stable.
  • Patients having no other physical problems than amputation.
  • Patient aged between 15 and 30 years.
  • year post amputation and ambulatory with a prosthesis.
  • Both male and female patients

You may not qualify if:

  • Amputees other than trans-tibial amputees.
  • Patients having other cause of amputation than traumatic.
  • Requiring intervention before the amputation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PIPOS Rehabilitation Services Program

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (6)

  • Jabeen N, Malik S. Prevalence and pattern of traumatic limb amputations in female population of Bhimber District, Azad Jammu and Kashmir, Pakistan. Pak J Med Sci. 2015 Jan-Feb;31(1):54-9. doi: 10.12669/pjms.311.6423.

    PMID: 25878614BACKGROUND
  • Kwan MK, Penafort R, Saw A. Treatment for flexion contracture of the knee during Ilizarov reconstruction of tibia with passive knee extension splint. Med J Malaysia. 2004 Dec;59 Suppl F:39-41.

    PMID: 15941159BACKGROUND
  • Ghazali MF, Abd Razak NA, Abu Osman NA, Gholizadeh H. Awareness, potential factors, and post-amputation care of stump flexion contractures among transtibial amputees. Turk J Phys Med Rehabil. 2018 Jul 12;64(3):268-276. doi: 10.5606/tftrd.2018.1668. eCollection 2018 Sep.

    PMID: 31453521BACKGROUND
  • Yigiter K, Sener G, Erbahceci F, Bayar K, Ulger OG, Akdogan S. A comparison of traditional prosthetic training versus proprioceptive neuromuscular facilitation resistive gait training with trans-femoral amputees. Prosthet Orthot Int. 2002 Dec;26(3):213-7. doi: 10.1080/03093640208726650.

    PMID: 12562068BACKGROUND
  • Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.

    PMID: 15449976BACKGROUND
  • Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.

    PMID: 22319684BACKGROUND

Study Officials

  • Shafaq Shahid, MSPT(OMPT)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

December 1, 2019

Primary Completion

December 20, 2020

Study Completion

December 20, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations