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Effectiveness of limb visualization system training on balance and cognitive function Improvement in Patients with Transtibial Amputations

Effectiveness of limb visualization system training on balance and cognitive function Improvement in Patients with Transtibial Amputations

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251125004
Enrollment
44
Registered
2025-11-25
Start date
2025-08-18
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transtibial Amputation (TTA) Transtibial Amputation (TTA)

Interventions

Participants in this arm receive Traditional Physical Therapy (standard of care for transtibial amputations) combined with Mobility XP Virtual Reality Training, focusing on balance and gait enhancemen
Experimental Behavioral,No Intervention Behavioral
VR Training and Traditional Physical Therapy,Traditional Physical Therapy

Sponsors

Strategic Research Fund, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Unilateral transtibial amputation < 12 months or received new prosthetic components 2. Medium to long residual limb length (over 30%: Stump length is classified by the ratio of the stump length to the sound leg length) 3. Age between 18-75 years old 4. Has functional level 1-4: Amputees has ability to use prothesis for transfer, ambulation and walk at least on the level surface at fixed cadence. 5. Participants can walk for a long time, at least 10 meters, on their own without any help or any gait aid 6. Participants must be in good general health, defined as having no acute medical conditions, no uncontrolled chronic diseases (e.g., uncontrolled hypertension or diabetes), and no recent history of hospitalization or major surgery within the past three months. 7. Normal range of motion (ROM) in all joints the lower limb joints 8. Lower limb muscle strength grade 4-5 according to Oxford scale 9. Able to comply with directions and comprehend written and spoken Thai 10. MIQ-RS score > 4 (Movement Imagery Questionnaire-Revised Second Version) (35) 11. A 1:1 ratio of right-handed to left-handed individuals will be maintained, with equal numbers of participants in each group.

Exclusion criteria

Exclusion criteria: 1. A residual limb with wounds, congestion, or extreme volume changes 2. An amputee with Uncontrolled diabetes, Uncontrolled hypertension, or other severe medical conditions 3. An amputee who has problems with the contralateral side which can influence the gait 4. An amputee with joint or muscle contractures either on the amputated side or contralateral side 5. An amputee who has cognitive impairment 6. An amputee who are allergic to the gel used for EEG measurement

Design outcomes

Primary

MeasureTime frame
Balance/Biomechanics before and after training 1. Kinematic data : Spatiotemporal gait parameters, lower limb joint angles during walking 2. Kinetic data: Ground reaction force (GRF) , Center of gravity (COG) , Base of support (BOS),Cognitive Function before and after training QEEG data at rest and Event-Related Potentials (ERPs) during a Go/No-go task

Secondary

MeasureTime frame
Phantom Limb Pain and Residual Limb Pain assessesment before and after training Visual Analog Scale (VAS),Amputee Mobility Predictor (AMP) before and after training K-level of amputee

Countries

Thailand

Contacts

Public ContactManunchaya Samala

Sirindhorn School of Prosthetics and Orthotics, Faculty of Medicine Siriraj Hospital, Mahidol University

manunchaya.saa@mahidol.ac.th0909836639

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026