AmputationNCT04588753
Active Isolated Stretch and Post Facilitation Stretch on Hamstring Flexibility in Trans-tibial Amputees.
A study testing active isolated stretch and Post Facilitation Stretch in people with Amputation, run by Riphah International University at 1 site in Pakistan.
Trial 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 . Read more about this study
- Who is it for?
- Ages 15 to 30 years
- Conditions the study is for
- Amputation
- What is being tested?
- active isolated stretch and Post Facilitation Stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2019to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 1 year post amputation and ambulatory with a prosthesis.
- Both male and female patients
Who cannot join
- Amputees other than trans-tibial amputees.
- Patients having other cause of amputation than traumatic.
- Requiring intervention before the amputation
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
PIPOS Rehabilitation Services Program
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Official title: Comparison of Active Isolated Stretch and Post Facilitation Stretch on Hamstring Flexibility in Trans-tibial Amputees
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.
Read the detailed description
Trans-tibial amputation (Below-knee amputation) that involves removing the foot, ankle joint and distal tibia and fibula with related soft tissue structures . Amputations occurs due to variety of reasons including trauma, diseases, tumors, infections and congenital malformations .Traumatic amputations tend to occur in younger and active age and in Pakistani amputee population the majority 65-70% the cause of amputation is traumatic and 50-60% are Trans-tibial amputations. Several complications related to the amputation-prosthesis interface needs attention while managing amputees including joint full range of motion especially in the joint immediately proximal to the amputation site. The trans-tibial amputees are prone to develop flexion deformity of the knee . Normal active range of motion of the knee is 0° extension and 140° flexion. In many people after Tran's tibial amputation with a flexion deformity, active range of motion of the ipsilateral knee is reduced . The main cause of occurrence of flexion deformity of the knee is the muscle shortening and tightness especially the hamstrings muscles due to the long periods in a bending position or inactivity due to the illness or lack of exercise .
Muscle Energy Techniques are used for lengthening of the muscles and improve range of motion (ROM) in joints . Active Isolated Stretching (AIS) is a uniquely effective exercise system with the advantages of specificity, active initiation, Incremental assists, Gentle motion, Brief duration, Multiple repetitions and Deep breathing. To stretch the hamstring muscles by lifting the leg straight up, stay on the mid-sagittal plane (keep the legs parallel). If the leg rotates out to the side, you lose much of the hamstring stretch and start affecting other muscles instead . While In Post Facilitation Stretch technique the hypertonic and shortened muscle is placed between a fully stretched and a fully relaxed state. Contracture of hamstrings using a maximum degree of effort for 5-10 seconds while the therapist resists the force. After this relaxation is done and effort is released and the therapist applies a rapid stretch to a new barrier and is held for 15 seconds. The relaxation is for 20 seconds and the procedure is repeated between three to five times and five times more .
Study concluded that the AIS helps to restore the deteriorated flexibility of the muscles . In 2013 study concluded compare the Muscle Energy Techniques with static stretches' for increasing hamstring flexibility in post burn patients. Their results shows that Both treatment groups had highly significant gains in knee extension ROM after 5 and 8 days post stretching exercises. But MET had highly significant gains in knee extension ROM than static stretching after 8 days of treatments .
In 2014 studied the three groups of 60 male students of Semnan University of Medical Sciences having shortened hamstring muscles. The 1st group underwent the hold relax technique, 2nd group underwent static stretches' and the 3rd group with no interventions for 4 weeks and three times a week. Results were recorded with goniometer before and after the sessions. Their results showed that both methods have a significant effect on increasing the motion range of knee. But no significant difference was observed between the static stretch and hold-relax techniques .
In 2019 study reviewed 4 studies related to active isolated stretches' for knee extension who evaluated 53 subjects who performed knee extension stretches 4 times a week for 4 weeks. The increase in ROM was statistically significant after the 1st week of AIS and in static stretches after 2 to 4 weeks. The AIS increase in ROM was significantly greater than for the static stretch exercise. Another study studied 30 subjects and their results showed that both modes of stretching significantly increased ROM, but AIS increased ROM significantly more than the static stretch exercise. Another study evaluated 30 subjects and reported that only the AIS significantly increased ROM. study reported on 30 subjects concluded that AIS increased ROM more than 11% versus the 8% by static stretch but the difference was not statistically significant .
- Conditions
- Amputation
- Being tested
- active isolated stretch, Post Facilitation Stretch
- Keywords
- Trans-tibial Amputees, Isolated Stretch, Post Facilitation Stretch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active isolated stretchOther
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
Post Facilitation StretchOther
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).
- Other amputees training exercises;
- weight-shifting
- Dynamic balancing activities
- Stool stepping
- Braiding
- Gait exercises
- Climbing/descending the stairs
| Study group | Role | What they receive |
|---|---|---|
| Active Isolated Stretch | Active comparator | active isolated stretching, strengthening exercises Receives: Other: active isolated stretch |
| Post Facilitation Stretch | Active comparator | Post Facilitation Stretching, strengthening exercises Receives: Other: Post Facilitation Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Dec 2019
- Primary completion20 Dec 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shafaq Shahid, MSPT(OMPT), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588753
- Sponsor's protocol ID
- REC/00680 Tehmina Khan
- Status last verified
- Dec 2020
- First submitted
- 9 Oct 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25878614Kwan 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.
PubMed 15941159Ghazali 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.
PubMed 31453521Yigiter 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.
PubMed 12562068Wrisley 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.
PubMed 15449976Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.
PubMed 22319684
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Active Isolated Stretch and Post Facilitation Stretch on Hamstring Flexibility in Trans-tibial Amputees
- ClinicalTrials.gov ID
- NCT04588753
- Acronym / sponsor ID
- REC/00680 Tehmina Khan
- Conditions
- Amputation
- Keywords
- Trans-tibial Amputees, Isolated Stretch, Post Facilitation Stretch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Trans-tibial amputation (Below-knee amputation) that involves removing the foot, ankle joint and distal tibia and fibula with related soft tissue structures . Amputations occurs due to variety of reasons including trauma, diseases, tumors, infections and congenital malformations .Traumatic amputations tend to occur in younger and active age and in Pakistani amputee population the majority 65-70% the cause of amputation is traumatic and 50-60% are Trans-tibial amputations. Several complications related to the amputation-prosthesis interface needs attention while managing amputees including joint full range of motion especially in the joint immediately proximal to the amputation site. The trans-tibial amputees are prone to develop flexion deformity of the knee . Normal active range of motion of the knee is 0° extension and 140° flexion. In many people after Tran's tibial amputation with a flexion deformity, active range of motion of the ipsilateral knee is reduced . The main cause of occurrence of flexion deformity of the knee is the muscle shortening and tightness especially the hamstrings muscles due to the long periods in a bending position or inactivity due to the illness or lack of exercise .
Muscle Energy Techniques are used for lengthening of the muscles and improve range of motion (ROM) in joints . Active Isolated Stretching (AIS) is a uniquely effective exercise system with the advantages of specificity, active initiation, Incremental assists, Gentle motion, Brief duration, Multiple repetitions and Deep breathing. To stretch the hamstring muscles by lifting the leg straight up, stay on the mid-sagittal plane (keep the legs parallel). If the leg rotates out to the side, you lose much of the hamstring stretch and start affecting other muscles instead . While In Post Facilitation Stretch technique the hypertonic and shortened muscle is placed between a fully stretched and a fully relaxed state. Contracture of hamstrings using a maximum degree of effort for 5-10 seconds while the therapist resists the force. After this relaxation is done and effort is released and the therapist applies a rapid stretch to a new barrier and is held for 15 seconds. The relaxation is for 20 seconds and the procedure is repeated between three to five times and five times more .
Study concluded that the AIS helps to restore the deteriorated flexibility of the muscles . In 2013 study concluded compare the Muscle Energy Techniques with static stretches' for increasing hamstring flexibility in post burn patients. Their results shows that Both treatment groups had highly significant gains in knee extension ROM after 5 and 8 days post stretching exercises. But MET had highly significant gains in knee extension ROM than static stretching after 8 days of treatments .
In 2014 studied the three groups of 60 male students of Semnan University of Medical Sciences having shortened hamstring muscles. The 1st group underwent the hold relax technique, 2nd group underwent static stretches' and the 3rd group with no interventions for 4 weeks and three times a week. Results were recorded with goniometer before and after the sessions. Their results showed that both methods have a significant effect on increasing the motion range of knee. But no significant difference was observed between the static stretch and hold-relax techniques .
In 2019 study reviewed 4 studies related to active isolated stretches' for knee extension who evaluated 53 subjects who performed knee extension stretches 4 times a week for 4 weeks. The increase in ROM was statistically significant after the 1st week of AIS and in static stretches after 2 to 4 weeks. The AIS increase in ROM was significantly greater than for the static stretch exercise. Another study studied 30 subjects and their results showed that both modes of stretching significantly increased ROM, but AIS increased ROM significantly more than the static stretch exercise. Another study evaluated 30 subjects and reported that only the AIS significantly increased ROM. study reported on 30 subjects concluded that AIS increased ROM more than 11% versus the 8% by static stretch but the difference was not statistically significant .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Isolated Stretch | Active comparator | Other: active isolated stretchactive isolated stretching, strengthening exercises |
| Post Facilitation Stretch | Active comparator | Other: Post Facilitation StretchPost Facilitation Stretching, strengthening exercises |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- Amputees other than trans-tibial amputees.
- Patients having other cause of amputation than traumatic.
- Requiring intervention before the amputation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active isolated stretchActive 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 | Other | Active Isolated Stretch |
| Post Facilitation StretchParticipants 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 | Other | Post Facilitation Stretch |
Primary outcome
Active Knee Extension Test (AKE)
Time frame: 2 weeks
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Background: PubMed 25878614Jabeen 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.
- Background: PubMed 15941159Kwan 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.
- Background: PubMed 31453521Ghazali 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.
- Background: PubMed 12562068Yigiter 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.
- Background: PubMed 15449976Wrisley 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.
- Background: PubMed 22319684Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafaq Shahid, MSPT(OMPT) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active isolated stretch and Post Facilitation Stretch in people with Amputation, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Knee Extension Test (AKE) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04588753, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.