Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05569967
NCT05569967CompletedNot Applicable

COMPARISON OF THE EFFECTS OF TELEREHABILITATION AND FACE-TO-FACE SPINAL STABILIZATION TRAININGS ON GAIT BIOMECHANICS, BALANCE AND JOINT POSITION SENSE IN TRANSTIBIAL AMPUTEES: A RANDOMIZED CONTROLLED, SINGLE BLIND STUDY

Ankara Yildirim Beyazıt University1 site in 1 country28 target enrollmentStarted: October 25, 2022Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
28
Locations
1
Primary Endpoint
gait speed
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

After transtibial amputations, biomechanical changes in the trunk, pelvis, and lumbar region cause asymmetrical strength and core muscle activation on the amputated side, which negatively affects the gait biomechanics of individuals. However, routine treatment programs do not use treatment approaches based on the core region. This study will focus on the effects of telerehabilitation and face-to-face spinal stabilization exercise training on gait, balance, joint position sense, core muscle function, and perceived mobility in transtibial amputees, after treatment, and after long-term follow-up.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Individuals who use total contact sockets
  • •have been using prostheses for at least 1 year,
  • •can walk independently without a walking aid
  • •functionally at least K2

Exclusion Criteria

  • •Bilateral amputation
  • •Upper extremity amputation
  • •Neurological problems
  • •Other orthopedic problems

Outcomes

Primary Outcomes

gait speed

Time Frame: Change from baseline at 8 weeks and 5 months

Participants will be asked to walk on flat ground for 10 meters. At this time, the speed will be evaluated by the BTS G-Walk sensor.

Secondary Outcomes

  • Core Muscle Endurance- Side Bridge(Change from baseline at 8 weeks and 5 months)
  • Stance symmetry(Change from baseline at 8 weeks and 5 months)
  • spatial parameter of gait(Change from baseline at 8 weeks and 5 months)
  • Core Muscle Endurance- Trunk Extansor(Change from baseline at 8 weeks and 5 months)
  • Step symmetry(Change from baseline at 8 weeks and 5 months)
  • temporal parameter of gait(Change from baseline at 8 weeks and 5 months)
  • Dynamic Balance(Change from baseline at 8 weeks and 5 months)
  • Balance confidence(Change from baseline at 8 weeks and 5 months)
  • Core Muscle Endurance- Trunk Flexor(Change from baseline at 8 weeks and 5 months)
  • Perceived Mobility(Change from baseline at 8 weeks and 5 months)
  • Joint Position Sense-Trunk(Change from baseline at 8 weeks and 5 months)
  • pelvic parameter of gait(Change from baseline at 8 weeks and 5 months)
  • Core Muscle Strength(Change from baseline at 8 weeks and 5 months)
  • Joint Position Sense-Knee(Change from baseline at 8 weeks and 5 months)

Investigators

Sponsor
Ankara Yildirim Beyazıt University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Comparison of Transtibial and Transfemoral Amputees' Posture ParametersTraumatic, Limb AmputationDefect Postural
NCT04456244Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey29
Recruiting
Not Applicable
Dynamic Balance in Unilateral Transtibial Amputees Following Virtual Reality Versus Conventional RehabilitationAmputees / RehabilitationVirtual RealityPostural Balance
NCT06424249Centre Hospitalier Universitaire de Nīmes20
Completed
Not Applicable
The Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral AmputeesTransfemoral AmputeesKinesiology Taping
NCT04644991Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey26
Completed
Not Applicable
Comparison of Different Amputation LevelsAmputeePlantar Pressure DistrubutionBalance
NCT04330274Marmara University85
Recruiting
Not Applicable
Technological Based Rehabilitation on Individuals With Rheumatic DiseaseRheumatic DiseasesHand RheumatismVirtual Reality Therapy
NCT06385574Akdeniz University45