- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04968691
Telerehabilitation in Individuals With Unilateral Transtibial Amputation
Investigation of Results of Structured Exercise Application Based on Telerehabilitation in Individuals With Unilateral Transtibial Amputation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Amputation is a major trauma that significantly disrupts the biomechanics of the musculoskeletal system, results in serious physical and psychological loss, and completely affects the quality of life, social and professional life of the individual. Due to the increase in the elderly population and the incidence of diabetes and vascular diseases in the world, the number of individuals with amputation is increasing day by day. Approximately 150,000 lower extremity amputations are performed each year in the United States alone. The number of amputated individuals worldwide is expected to double by 2050. The most common amputation level in the world and in our country is transtibial amputations and approximately 39% of all amputations are performed at this level. In addition, the most common prosthesis use among individuals with lower extremity amputations is seen in those with the transtibial amputation level. Individuals who have undergone transtibial amputation have lost the foot-ankle complex and all related muscular functions. After transtibial amputation surgery, loss of proprioceptive information occurs in ankle control and in foot-ankle and all lower extremity muscles due to loss of exteroceptors around the foot. This leads to loss of balance during standing, stepping, and walking.
Physiotherapy and rehabilitation practices are needed in order for individuals with amputations to use their prostheses effectively and have a successful prosthesis adaptation. After the transtibial amputation, early period physiotherapy applications are followed by the use of prosthesis, and prosthetic period rehabilitation applications are continued. Prosthetic rehabilitation in individuals with transtibial amputation; aims to provide balance by taking into account the losses after amputation, to gain close to normal walking with minimum energy consumption, to ensure maximum independence in a safe manner by taking into account the pre-amputation lifestyles, expectations, and medical limitations of individuals. Physiotherapy and rehabilitation practices in individuals with transtibial amputation consist of a long-term process that starts before amputation and includes the early period after amputation, the prosthetic period, and returns to social life. Factors such as the long-term physiotherapy needs of individuals with transtibial amputation, the presence of gait and balance problems, geographical conditions, financial inadequacies, and epidemic diseases may cause problems for these individuals to reach the physiotherapy and rehabilitation applications offered in health institutions. In order to facilitate participation in physiotherapy and rehabilitation practices and to reduce resource use, telerehabilitation practices are recommended for individuals with amputation, as with other diseases that require rehabilitation. It is thought that telerehabilitation can be a useful and practical method for individuals with transtibial amputation where it is difficult and tiring to go to the clinic.
In the literature, it has been observed that there are very few studies examining the effects of physiotherapy and rehabilitation on parameters such as muscle strength, balance, gait, performance, body image, prosthesis fit, prosthesis use satisfaction, and quality of life in the rehabilitation of individuals with transtibial amputation. In addition, there are very few studies in the literature that include telerehabilitation applications related to transtibial amputations, and there is no study that questions the effects of structured exercise programs. This study was planned in order to determine the effects of telerehabilitation applications on muscle strength, kinesiophobia, balance, activity limitation, body image, prosthesis compliance and satisfaction with use, and quality of life in individuals with transtibial amputation. It is aimed to guide physiotherapists whether they prefer telerehabilitation applications as an evidence-based practice among rehabilitation methods in this field.
It is aimed to investigate the effects of telerehabilitation-based structured exercise on muscle strength, balance, performance, body image, prosthesis adaptation, activity limitation, prosthesis use satisfaction, and quality of life in individuals with unilateral transtibial amputation.
In order to determine the number of samples in the study; the alpha significance level of the hypothesis was 0.05; the effect size was determined as 0.5 and power as 0.85. As a result of the analysis; The research will be carried out with a total of 40 people, 20 people in each group.
Forty individuals with a unilateral transtibial amputation will be included in the study. Participants will be divided into two groups as telerehabilitation and control groups with equal sample sizes by the randomization method. All participants will undergo a 6-week exercise program. A structured exercise program supported by telerehabilitation will be applied to the telerehabilitation group 3 days a week, and a home exercise program will be applied on the remaining days of the week. An only a home exercise program will be applied to the control group. Participants will be evaluated at the beginning and end of the study.
Method of the Study:
- A mobile telecommunication group will be formed, including the participants and the physiotherapist. Communication with the participants will be provided here. In addition, one-on-one or collective teleconferences will be held with the participants when necessary.
- Before each session, the telerehabilitation group will be shown how to do the exercises online by the researcher, and it will be ensured that the patients do the exercises correctly and are followed up. In addition, at the beginning of each week, videos with the exercise content of that week will also be sent.
- The control group will be given exercise cards showing the home exercise program at the beginning of the treatment.
- Tracking of the exercises will be done with the exercise diary Statistical analysis: In the analysis of the data, statistical analysis including a descriptive, comparator, and correlation will be made. Mean, standard deviation and percentage distributions will be calculated for descriptive data. In the analysis of the repeated measurement results of the scales, ANOVA will be applied for the data conforming to the normal distribution. The student's t-test will be used for parametric data and Mann Whitney-U test for non-parametric data.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul University-Cerrahpasa Faculty of Health Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having a unilateral transtibial amputation
- Using active vacuum system prosthesis and carbon foot for at least one year
- Being at the level of mobility level K2-K3
- Not having any problems in the healthy leg
- A score of 21 or higher on the Montreal cognitive assessment scale (MOCA)
Exclusion Criteria:
- Patients who received physical therapy in the last 6 months
- Having a neurological, orthopedic, and systemic condition that will prevent them from exercising
- Having any orthopedic and neurological problems in the upper extremity
- Having severe hearing, vision, and speech impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telerehabilitation group
The group to which a structured exercise program supported by telerehabilitation will be treated.
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The telerehabilitation group will be shown how to do the exercises online by the researcher before each session, 3 sessions a week for 6 weeks, with mobile telecommunication applications, and it will be ensured that the patients do the exercises correctly and are followed up.
In addition, at the beginning of each week, videos with the exercise content of that week will also be sent.
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Active Comparator: Control group
The group to which the home exercise program will be treated.
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n the study, exercise cards were given to the control group and the exercise treatment they were asked to do at home 3 sessions a week for 6 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Timed Up and Go test
Time Frame: up to 20 weeks
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The Timed Up and Go test is a simple test used to assess a person's mobility and requires both static and dynamic balance.
It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.
During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require.
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up to 20 weeks
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30 Second Sit to Stand Test
Time Frame: up to 20 weeks
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lso known as a 30-second chair stand test, this test is a way to assess an individual's leg strength and endurance by having them stand up from a sitting position repeatedly over the course of 30 seconds.
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up to 20 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trinity Amputation and Prosthesis Experiences Scales (TAPES)
Time Frame: up to 20 weeks
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TAPES consists of 9 subscales.
There are 3 psychosocial subscales: general adjustment , social adjustment, and adjustment to limitation.
Scores range from 5 to 25, with higher scores indicating greater levels of adjustment.
The TAPES also contain 3 activity restriction subscales: functional activity restriction , social activity restriction , and athletic activity restriction .
Scores range from 3 to 12, with higher scores indicating greater activity restriction.
There are 3 additional subscales that assess satisfaction with the prosthesis, measured along a 5-point scale (very dissatisfied, dissatisfied, neither dissatisfied nor satisfied, satisfied, very satisfied).
Higher scores in each of the satisfaction subscales indicate greater satisfaction with the prosthesis.
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up to 20 weeks
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Activities-specific Balance Confidence Scale (ABC Scale)
Time Frame: up to 20 weeks
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The ABC scale contains 16 tasks related to indoor and outdoor daily living activities, to measure balance confidence in elderly people who have various levels of functioning.
Scores range from 0% (no confidence) to 100% (complete confidence) for each question item.
Higher scores indicate greater confidence.
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up to 20 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Amputee Body Image Scale (ABIS)
Time Frame: up to 20 weeks
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ABIS is comprised of 20 items.
The response to each item ranges from 1 (none of the time) to 5 (all of the time).
This scale produces scores that range from 20-100, with high scores indicating high body image disturbance.
Three questions (question 3, 12 and 16) are reverse-scored.
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up to 20 weeks
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The Nottingham Health Profile
Time Frame: up to 20 weeks
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The Nottingham Health Profile (NHP) is a general patient-reported outcome measure which seeks to measure subjective health status.
It is a questionnaire designed to measure a patient's view of their own health status, in a number of areas.
The NHP consists of two parts.
The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation.
The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays.
Scoring is straightforward, with 0 assigned to a 'no' response and 1 to a 'yes' response.
Scores for each of the sections range between 0 ('worst health') and 100 ('best health').
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up to 20 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mehmet Kurtaran, MSc, Istanbul Universtiy- Cerrahpasa
- Study Director: Derya Çelik, PhD, Istanbul Universtiy- Cerrahpasa
Publications and helpful links
General Publications
- Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
- Highsmith MJ, Kahle JT, Miro RM, Orendurff MS, Lewandowski AL, Orriola JJ, Sutton B, Ertl JP. Prosthetic interventions for people with transtibial amputation: Systematic review and meta-analysis of high-quality prospective literature and systematic reviews. J Rehabil Res Dev. 2016;53(2):157-84. doi: 10.1682/JRRD.2015.03.0046. Review.
- Davie-Smith F, Paul L, Nicholls N, Stuart WP, Kennon B. The impact of gender, level of amputation and diabetes on prosthetic fit rates following major lower extremity amputation. Prosthet Orthot Int. 2017 Feb;41(1):19-25. doi: 10.1177/0309364616628341. Epub 2016 Jul 9.
- Dillingham TR, Pezzin LE, Shore AD. Reamputation, mortality, and health care costs among persons with dysvascular lower-limb amputations. Arch Phys Med Rehabil. 2005 Mar;86(3):480-6. doi: 10.1016/j.apmr.2004.06.072.
- Hsu MJ, Nielsen DH, Lin-Chan SJ, Shurr D. The effects of prosthetic foot design on physiologic measurements, self-selected walking velocity, and physical activity in people with transtibial amputation. Arch Phys Med Rehabil. 2006 Jan;87(1):123-9.
- Hofstad CJ, van der Linde H, Nienhuis B, Weerdesteyn V, Duysens J, Geurts AC. High failure rates when avoiding obstacles during treadmill walking in patients with a transtibial amputation. Arch Phys Med Rehabil. 2006 Aug;87(8):1115-22.
- Broomhead P, Clark K, Dawes D, Hale C, Lambert A, Quinlivan D, et al. Evidence-based clinical guidelines for the physiotherapy management of adults with lower limb prostheses. Chartered Society of Physiotherapy. 2012, 2nd. London.
- Rintala DH, Krouskop TA, Wright JV, Garber SL, Frnka J, Henson HK, Itani KM, Gaddis W, Matamoros R, Monga TN. Telerehabilitation for veterans with a lower-limb amputation or ulcer: Technical acceptability of data. J Rehabil Res Dev. 2004 May;41(3B):481-90.
- Nelson VS, Flood KM, Bryant PR, Huang ME, Pasquina PF, Roberts TL. Limb deficiency and prosthetic management. 1. Decision making in prosthetic prescription and management. Arch Phys Med Rehabil. 2006 Mar;87(3 Suppl 1):S3-9. Review.
- Jones CJ, Rikli RE. Measuring functional fitness of older adults. J Active Aging. 2002; 24-30.
- Ayhan Ç, Büyükturan Ö, Kırdı N, Yakut Y, Güler Ç. The Turkish vercion of the Activites Specific Balance Confidence (ABC) Scale: Its cultural adaptation, validation and reliability in older adults. Turkish Journal of Geriatrics, 2014;17(2),157-163.
- Topuz S, Ülger Ö, Yakut Y, Gül Şener F. Reliability and construct validity of the Turkish version of the Trinity Amputation and Prosthetic Experience Scales (TAPES) in lower limb amputees. Prosthet Orthot Int. 2011 Jun;35(2):201-6. doi: 10.1177/0309364611407678.
- Bumin G, Bayramlar K, Yakut Y, Sener GY. Cross cultural adaptation and reliability of the Turkish version of Amputee Body Image Scale (ABIS). J Back Musculoskelet Rehabil. 2009;22(1):11-6. doi: 10.3233/BMR-2009-0208.
- Demet K, Guillemin F, Martinet N, André JM. Nottingham Health Profile: reliability in a sample of 542 subjects with major amputation of one or several limbs. Prosthet Orthot Int. 2002 Aug;26(2):120-3.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A-15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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