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Telerehabilitation in Individuals With Unilateral Transtibial Amputation

8 juli 2021 bijgewerkt door: Mehmet Kurtaran

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

      • Istanbul, Kalkoen
        • Istanbul University-Cerrahpasa Faculty of Health Science

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Telerehabilitation group
The group to which a structured exercise program supported by telerehabilitation will be treated.
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.
Actieve vergelijker: Control group
The group to which the home exercise program will be treated.
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Timed Up and Go test
Tijdsspanne: up to 20 weeks
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.
up to 20 weeks
30 Second Sit to Stand Test
Tijdsspanne: up to 20 weeks
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.
up to 20 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Trinity Amputation and Prosthesis Experiences Scales (TAPES)
Tijdsspanne: up to 20 weeks
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.
up to 20 weeks
Activities-specific Balance Confidence Scale (ABC Scale)
Tijdsspanne: up to 20 weeks
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.
up to 20 weeks

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Amputee Body Image Scale (ABIS)
Tijdsspanne: up to 20 weeks
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.
up to 20 weeks
The Nottingham Health Profile
Tijdsspanne: up to 20 weeks
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').
up to 20 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Onderzoekers

  • Hoofdonderzoeker: Mehmet Kurtaran, MSc, Istanbul Universtiy- Cerrahpasa
  • Studie directeur: Derya Çelik, PhD, Istanbul Universtiy- Cerrahpasa

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 augustus 2021

Primaire voltooiing (Verwacht)

31 december 2021

Studie voltooiing (Verwacht)

31 december 2022

Studieregistratiedata

Eerst ingediend

7 juli 2021

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2021

Eerst geplaatst (Werkelijk)

20 juli 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 juli 2021

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2021

Laatst geverifieerd

1 juli 2021

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Beschrijving IPD-plan

All IPD that underlie results will not be shared

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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