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AmputationNCT04968691

Telerehabilitation in Individuals With Unilateral Transtibial Amputation

A study testing Telerehabilitation based exercise treatment and Home based exercise treatment in people with Amputation and Telerehabilitation, run by Mehmet Kurtaran at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 below-knee amputation. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Amputation, Telerehabilitation, Exercise
What is being tested?
Telerehabilitation based exercise treatment and Home based exercise treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2021to 31 Dec 2022
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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpaşa Faculty of Health Science

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of Results of Structured Exercise Application Based on Telerehabilitation in Individuals With Unilateral Transtibial Amputation

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 below-knee amputation. Study hypothesis: In individuals with transtibial amputation, telerehabilitation-based structured exercise has an effect on muscle strength, balance, performance, body image, prosthesis adaptation, activity limitation, prosthesis use satisfaction, and quality of life. 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.

Read the 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.
Being tested
Telerehabilitation based exercise treatment, Home based exercise treatment
Keywords
Transtibial Amputation, Below Knee Amputation, Transtibial Prosthesis Users, Below Knee Prosthesis Users, Telerehabilitation, Amputees Rehabilitation, Exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation based exercise treatmentOther

    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.

  • Home based exercise treatmentOther

    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

Study groups in NCT04968691
Study groupRoleWhat they receive
Telerehabilitation groupExperimentalThe group to which a structured exercise program supported by telerehabilitation will be treated.
Receives: Other: Telerehabilitation based exercise treatment
Control groupActive comparatorThe group to which the home exercise program will be treated.
Receives: Other: Home based exercise treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Timed Up and Go test

    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.

    Measured: up to 20 weeks

  2. 30 Second Sit to Stand Test

    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.

    Measured: up to 20 weeks

Secondary outcomes (2)
  1. Trinity Amputation and Prosthesis Experiences Scales (TAPES)

    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.

    Measured: up to 20 weeks

  2. Activities-specific Balance Confidence Scale (ABC Scale)

    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.

    Measured: up to 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start1 Aug 2021 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968691
Sponsor's protocol ID
A-15
Status last verified
Jul 2021
First submitted
7 Jul 2021
Last updated
20 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All IPD that underlie results will not be shared

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.

    PubMed 18295618
  • 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.

    PubMed 27149143
  • 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.

    PubMed 26850990
  • 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.

    PubMed 15759232
  • 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. doi: 10.1016/j.apmr.2005.07.310.

    PubMed 16401450
  • 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. doi: 10.1016/j.apmr.2006.04.009.

    PubMed 16876558
  • 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. doi: 10.1682/jrrd.2004.03.0481.

    PubMed 15543466
  • 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. doi: 10.1016/j.apmr.2005.11.022.

    PubMed 16500187
  • 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, Ulger O, Yakut Y, Gul Sener 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.

    PubMed 21697202
  • 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.

    PubMed 20023358
  • Demet K, Guillemin F, Martinet N, Andre 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. doi: 10.1080/03093640208726634.

    PubMed 12227446
  • B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.

    PubMed 37276273

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation based exercise treatment and Home based exercise treatment in people with Amputation and Telerehabilitation, run by Mehmet Kurtaran at 1 site in Turkey (Türkiye).

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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Jul 2021. 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 Turkey (Türkiye). 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?

Results are not available in the source record.

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?

The Timed Up and Go test (time frame: up to 20 weeks). The study lists 2 primary outcomes in all. 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 NCT04968691, which also lists 15 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 20 Jul 2021.

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