Longitudinal monitoring of neuromuscular, biomechanical, clinical and psychological function in transtibial amputees and possible implications for individually optimised rehabilitation processes.

Longitudinal monitoring of neuromuscular, biomechanical, clinical and psychological function in transtibial amputees and possible implications for individually optimised rehabilitation processes. - LoMoTTA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035295

Enrollment

Registered

2025-04-08

Start date

2026-02-01

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Z89.5 Z89.7

Interventions

Group 1: Transtibial Amputees Tests/Measurements: - Force-, Muscle- and brain actvity measurements (Force, EMG, EEG) during isometric knee extension & -flexion and Plantarflexion & -extension (Imagin

final prosthetic device (12 mths post-amputation) 7. (if possible) follow-up 2 (18 mths post-amputation) 8. (if possible) follow-up 3 (24 mths post-amputation) Group 2: Control Group Tests/Measurement

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - unilateral or bilateral transtibial amputees - sufficient kognitive function to understand patient information, informed consent and testing instructions

Exclusion criteria

Exclusion criteria: - additional amputations - severe neurological diseases or handicaps that may influence the study outcomes - depression, anxiety or similar psychological diseases for which patients are in treatment

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the overall study are potential predictors of long-term rehabilitation success, which is why there is not just one primary endpoint. However, the focus here is on corticomuscular and intramuscular coherence, as well as the correlation of these coherences with final mobility. These parameters are measured as follows: - corticomuscular coherence: correlation between EEG and EMG signals during force application in knee and ankle movements - intermuscular coherence: correlation between EMG signals of involved muscles - Gait symmetry (gait analysis with IMUs: stride length, stride width, speed, etc.) - Balance (sway of the CoP in bipedal stance on force plates) - Mobility (performance in 2MWT, L-test)	—

Measure

Time frame

The primary endpoint of the overall study are potential predictors of long-term rehabilitation success, which is why there is not just one primary endpoint. However, the focus here is on corticomuscular and intramuscular coherence, as well as the correlation of these coherences with final mobility. These parameters are measured as follows: - corticomuscular coherence: correlation between EEG and EMG signals during force application in knee and ankle movements - intermuscular coherence: correlation between EMG signals of involved muscles - Gait symmetry (gait analysis with IMUs: stride length, stride width, speed, etc.) - Balance (sway of the CoP in bipedal stance on force plates) - Mobility (performance in 2MWT, L-test)

—

Secondary

Measure	Time frame
Secondary outcomes are further possible predictors or influencial factors: - health/disease status & care situation (registerede in the Amputation register AMP-Kompass) - psychological well- being and mental health (questionnaires WHO-5 and PhQ-4) - Fear of falling and Kinesiophobia (Questionnaire FES-I) - Pain VAS-Scale, via AMP-Kompass)	—

Countries

Germany

Contacts

Public ContactJohanna Kubosch

Universitätsklinikum Freiburg, Klinik für Orthopädie und Unfallchirurgie

johanna.kubosch@uniklinik-freiburg.de+4976127074750

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026