Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202312646275553 Date of Approval: 13/12/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Phantom Exercise, Transcutenous Electrical Nerve Stimulation on Selected outcome measures of Patients with Lower Limb Amputation.
Official scientific title Effect of Phantom Exercise, Transcutenous Electrical Nerve Stimulation on Selected outcome measures of Patients with Lower Limb Amputation.
Brief summary describing the background and objectives of the trial Amputation is the surgical removal of either whole or part of limb through bone tissue while disarticulation is the removal of the limb at joint level.Amputation of any part of the limb is not only a loss physically, but it also affects the individual psychology and social life. Phantom limb pains (PLPs) is a painful sensation often experienced due to limb loss following amputation. Globally, amputation is among the most common contributors to large number of cases of disability in the community with as much as 30 million people worldwide. Rehabilitation programme is clinically designed to reduce the impact of the lost limb. This can be achieved through restoring of the function of impaired limb, improved abilities, and reducing the discrepancy between the limited ability of disabled people and the demands of their environment. The phantom exercise technique consists of active movements of the sound limb imagined movements of the phantom extremity like bridging, flexion/extension, abduction/adduction exercises and inversion/eversion. Soft tissue massage have been recognized for its effect in increasing blood circulation, systemically and locally Objectives of the study 1. To determine the effect of phantom exercise alone on pain, mobility and quality of life in patients with lower limb amputation 2. To determine the effect of phantom exercise plus TENS on pain, mobility and quality of life in patients with lower limb amputation. 3. To determine the effect of phantom exercise plus massage therapy on pain, mobility and quality of life in patients with lower limb amputation. 4. To determine the effect of conventional therapy on pain, mobility and quality of life of patients with lower limb amputation. 5. To compare the effect of phantom exercises alone, phantom exercise plus TENS, phantom exercise plus massage therapy and conventional therapy on pain, mobility and quality of life in patients with lower limb amputation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/10/2023
Actual trial start date 23/10/2023
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date 30/11/2023
Anticipated target sample size (number of participants) 36
Actual target sample size (number of participants) 19
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Phantom Exercise Intervention will be administered twice in a week (Tuesdays and Thursdays) for a period of 4 weeks for each patient Each patient will spend like 30 minutes duration to perform this exercise Protocol for phantom limb exercise (for above knee amputee) This protocol of exercise will be adopted from the study by Anna et al, (2021) and Royalberkshire, (2020) for 2 treatment sessions in a week, 5 second hold, relaxation time 2 or 3 repetitions. Bridging exercise: patient will be ask to lie supine, place the operated limb on a pillow or a couple of rolled towels, lift the opposite leg off the ground., press the operated leg down onto the pillow so that the hips are lifted off the bed and hold for 5 seconds. Then lowered gently and relaxed and repeat 2 times Anna et al, (2021) and Royalberkshire, (2020) Hip Abduction exercise: Patient will be instructed be in side lying with operated leg underneath and place a rolled up pillow under the leg, he will be ask to raised the upper leg and push the lower leg hard onto the pillow so that the hip and pelvis are raised off the bed or couch. Patient will hold for 5 seconds and then lower the upper leg gently and relax. The exercise will be perfomed twice Anna et al, (2021) and Royalberkshire, (2020). Hip Adduction exercise: Patient will be instructed to be in side lying with operated leg on top, resting on a pillow in between. The patient will be asked press the top leg strongly down onto the pillow and hold for 5 seconds, relax gently and repeat 3 times Anna et al, (2021) and Royalberkshire, (2020). Flexion /Extension exercise: Patient will lie supine, and will be instructed to flex his operated limb towards the abdomen and hold for 5 seconds and extend back to starting position. Then relax gently, he will repeat for 3 times Anna et al, (2021) and Royalberkshire, (2020). For below knee amputee Extension exercise: Patient will be instructed to kneel on both knees The patient will assured of safety in case of fall during this exercise. The operated leg and will be straight behind backward; once the patient is balanced, he will be instructed to raise the opposite arm and reach it out forward, hold the position for 5 5
Experimental Group Phantom exercise and Transcutenous Electrical Nerve Stimulation TENS Patient will receive phantom exercise and TENS twice in a week for 4 weeks Treatment will last for 45 minutes Protocol for phantom limb exercise (for above knee amputee) This protocol of exercise will be adopted from the study by Anna et al, (2021) and Royalberkshire, (2020) for 2 treatment sessions in a week, 5 second hold, relaxation time 2 or 3 repetitions. Bridging exercise: patient will be ask to lie supine, place the operated limb on a pillow or a couple of rolled towels, lift the opposite leg off the ground., press the operated leg down onto the pillow so that the hips are lifted off the bed and hold for 5 seconds. Then lowered gently and relaxed and repeat 2 times Anna et al, (2021) and Royalberkshire, (2020) Hip Abduction exercise: Patient will be instructed be in side lying with operated leg underneath and place a rolled up pillow under the leg, he will be ask to raised the upper leg and push the lower leg hard onto the pillow so that the hip and pelvis are raised off the bed or couch. Patient will hold for 5 seconds and then lower the upper leg gently and relax. The exercise will be perfomed twice Anna et al, (2021) and Royalberkshire, (2020). Hip Adduction exercise: Patient will be instructed to be in side lying with operated leg on top, resting on a pillow in between. The patient will be asked press the top leg strongly down onto the pillow and hold for 5 seconds, relax gently and repeat 3 times Anna et al, (2021) and Royalberkshire, (2020). Flexion /Extension exercise: Patient will lie supine, and will be instructed to flex his operated limb towards the abdomen and hold for 5 seconds and extend back to starting position. Then relax gently, he will repeat for 3 times Anna et al, (2021) and Royalberkshire, (2020). For below knee amputee Extension exercise: Patient will be instructed to kneel on both knees The patient will assured of safety in case of fall during this exercise. The operated leg and will be straight behind backward; once the patient is balanced, he will be instructed to raise the opposite arm and reach it out forward, hold the position for 5 5
Experimental Group Phantom exercise with massage therapy Patient will receive treatment twice in a week for 4 weeks Patient will spend at least 35 minutes on each intervention Protocol for phantom limb exercise (for above knee amputee) This protocol of exercise will be adopted from the study by Anna et al, (2021) and Royalberkshire, (2020) for 2 treatment sessions in a week, 5 second hold, relaxation time 2 or 3 repetitions. Bridging exercise: patient will be ask to lie supine, place the operated limb on a pillow or a couple of rolled towels, lift the opposite leg off the ground., press the operated leg down onto the pillow so that the hips are lifted off the bed and hold for 5 seconds. Then lowered gently and relaxed and repeat 2 times Anna et al, (2021) and Royalberkshire, (2020) Hip Abduction exercise: Patient will be instructed be in side lying with operated leg underneath and place a rolled up pillow under the leg, he will be ask to raised the upper leg and push the lower leg hard onto the pillow so that the hip and pelvis are raised off the bed or couch. Patient will hold for 5 seconds and then lower the upper leg gently and relax. The exercise will be perfomed twice Anna et al, (2021) and Royalberkshire, (2020). Hip Adduction exercise: Patient will be instructed to be in side lying with operated leg on top, resting on a pillow in between. The patient will be asked press the top leg strongly down onto the pillow and hold for 5 seconds, relax gently and repeat 3 times Anna et al, (2021) and Royalberkshire, (2020). Flexion /Extension exercise: Patient will lie supine, and will be instructed to flex his operated limb towards the abdomen and hold for 5 seconds and extend back to starting position. Then relax gently, he will repeat for 3 times Anna et al, (2021) and Royalberkshire, (2020). Massage therapy protocol The effleurage is rhythmical and continuous movement of the palmer surface of the hand and fingers to the skin in one direction only, with the aim of increasing blood flow in that direction, stretching tissues, relaxing the client and aiding the dispersal of waste products. It will begin with light touch at the start of t 5
Control Group Post operative management in the ward Daily From post operation to discharge Patient will receive normal postoperative management in form of medical and dressing till discharge 4 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Male or female patients with amputation ii. Either left or right lower limb amputation. iii. Patients who had amputation at least one week post-operative of the lower limb on admission. iv. Patients with lower limb amputation receiving physiotherapy treatment Patients with end stage renal disease ii. Patients having visual impairment iii. Patients with end stage carcinoma iv. Patients not able to give informed consent v. Patients with hearing impairment 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 17 Year(s) 98 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/11/2023 Clinical Research and Ethics Committe Abubakar Tafawa Balewa University Teaching Hospital Bauchi
Ethics Committee Address
Street address City Postal code Country
Hospital Road Off Yandoka Street P. M.B 0117, Bauchi Bauchi 0117 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome All interventions will give a better outcome for patients with amputation 2 minutes for NPRS, 20 minutes for AMPQ and 5 minutes for SF12.
Secondary Outcome This will serve as standard protocol for in rehabilitation of patients with phantom pain and mobility after amputation 2 minutes for NPRS, 20 minutes for AMPQ and 5 minutes for SF12. 30 Minutes for Phantom exercise, 15 minutes for TENS and 5 Minutes for Massage therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Abubakar Tafawa Balewa University Teaching Hospital Bauchi Bauchi state Nigeria Hospital Road off Yandoka street, Bauchi Bauchi 0117 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ishaku Ibrahim House No. 3 Ahlul Bait street, Opposite Annor Academy, Gubi Dam road, Bauchi, Bauchi State Bauchi 0117 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ishaku Ibrahim House No.3 Ahlul bait street, opposite Annor Academy, Gubi dam road, Bauchi, Bauchi State Bauchi 0117 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ashiyat Akodu akoduashiyat@gmail.com +2348034269053 Lagos University Teaching Hospital Staff Quarters House No. 10
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Sub Dean college of medicine University of Lagos
Role Name Email Phone Street address
Principal Investigator Olajide Olawale oolawale@unilag.edu.ng +2348080774586 Lagos University Teaching Hospital, Staff Quarters
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Head Physiotherapy Department college of Medicine University of Lagos
Role Name Email Phone Street address
Principal Investigator Alexander Gordons agesnky@yahoo.com +2348023747773 Staff quarters, Abubakar Tafawa Balewa University Teaching Hospital, Bauch, Bauchi State
City Postal code Country Position/Affiliation
Bauchi 0117 Nigeria Head Department of Physiotherapy
Role Name Email Phone Street address
Public Enquiries Daniel Odebiyi dodebiyi@unilag.edu.ng +2348024717968 College of Medicine, university of Lagos
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Postgraduate Coordinator
Role Name Email Phone Street address
Scientific Enquiries Gbonjubola Yusuff yusuffgbonjubola@gmail.com +2348131097836 Fada mada, Opposite Faria Foundation
City Postal code Country Position/Affiliation
Bauchi 0117 Nigeria Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Information and materials on individual Participant Data can be accessed through my contact and will make it available to other researchers within a specific time frame after publication. Analytic Code,Informed Consent Form,Study Protocol 4 weeks Through my contact
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information