Effects of Virtual Reality on Transtibial Amputation Physiotherapy Outcomes

NCT03872193 | Completed

• 1 other identifier: Virtual Reality Physiotherapy
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the effects of virtual reality applications on quality of life, performance, balance, prosthesis adaptation and gait parameters in individuals with transtibial amputation. 20 Transtibial amputee were included in study. All participants were using transtibial prothesis with active vacuum system at least 1 year. Participants were divided into two groups. While a group of virtual reality applications were being performed additionally standart physiotherapy, only standard physiotherapy methods were applied in the second group. Balance and gait practices were performed for each group. Individuals were treated for 3 days a week for 4 weeks, and individuals were evaluated before and after treatment. Individuals were evaluated for quality of life, performance, balance, prosthesis adaptation and time-distance parameters of walking.

Conditions

Virtual Reality

Keywords

Amputation; Virtual Reality; Rehabilitation

Outcome Measures

Primary Outcomes (5)

• Quality of Life measured of individuals: SF-36 Scale

  SF-36 Quality of Life Scale, higher values represent a better

  10 minute

• Balance Test

  Single Leg Balance Test,higher values represent a better

  5 minute

• Performance Test

  6 minute walk test,higher values represent a better

  6 minute

• Prothesis Satisfaction: Trinity Amputation Prothesis Experience Scale

  Trinity Amputation Prothesis Experience Scale; 5 point likert scale,5-75 point, activity limitation,physicosocial adaptation,prothesis satisfaction

  5 minute

• Gait Parameters

  Wearable Biometric Device

  6 minute

Study Arms (2)

Physio Therapy

EXPERIMENTAL

We intervention this group some routine exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees.

Other: Exercise

Virtual Reality

EXPERIMENTAL

This group had physical therapy program plus virtual reality exercises. They had balance exercises, gait training,incline surface gait,bloked surface gait training and recreational activities. Extremity strengthenin exercises,balance exercises and increasing endurance are applied for this amputees. And virtual reality exercises were done for this group. Skiing,kayak, football,rafting and jumping activities were done in this exerciese.

Other: Exercise

Interventions

Exercise OTHER

Virtual Reality Exercies

Physio Therapy; Virtual Reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• transtibial and unilateral amputation
• At least 1 year prothesis usage, 18- 65 year age,
• At least 15 min independent walking ability,
• Stabile stump volume,
• Standart stump lentgh,
• Enough kognition for evaluation and tests.

You may not qualify if:

• walking and other activities to prevent; shortness of muscle, limitation of joint motion and phantom pain in stump, presence of any discomfort or systemic health problem that may affect the gait outside the amputation
• presence of visual problems to prevent participation in virtual reality applications,
• use of walking aids

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (2)

• Yildirim Sahan T, Erbahceci F. Effects of Virtual Reality on Transtibial Amputation Rehabilitation Outcomes: A Randomized Study. Games Health J. 2023 Dec;12(6):459-467. doi: 10.1089/g4h.2023.0052. Epub 2023 Nov 7.

  PMID: 37934289 DERIVED

• 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.

  PMID: 37276273 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: One group only physiotherapy second group takes physiotherapy and virtual reality exercises.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 13, 2019
• Study Start: July 10, 2016
• Primary Completion: March 12, 2018
• Study Completion: June 10, 2018
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share