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Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery

Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery - Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060492
Enrollment
2
Registered
2026-03-01
Start date
2026-03-02
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

After tendon transfer surgery for upper limb motor dysfunction

Interventions

Surface electrodes are placed on the skin overlying the muscle bellies of the flexor carpi radialis and flexor carpi ulnaris. To suppress wrist joint movement and avoid compensatory MP joint motion ca
s voluntary movement intention. Training is initiated after confirming the absence of abnormal movements or pain. Joint motion assistance is provided in synchrony with the voluntary movement intention

Sponsors

the University of Osaka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals aged 20 years or older at the time of obtaining informed consent Patients in the chronic phase who have undergone tendon transfer surgery for upper limb motor dysfunction (finger MP joint extension impairment) and are at least 6 months postoperatively Patients with persistent upper limb motor dysfunction, including impaired finger MP joint extension, after tendon transfer surgery Patients who are medically judged by a physician to be eligible for training using the medical single-joint type Hybrid Assistive Limb (HAL) Individuals who fully understand the purpose and procedures of this study and have provided written informed consent of their own free will

Exclusion criteria

Exclusion criteria: Individuals with severe pain, skin disorders, wound infection, severe joint contracture, or other conditions at the HAL attachment sites (upper limb) that would prevent safe device application or training Individuals with severe cognitive impairment or psychiatric disorders that would make it difficult to understand the study procedures or comply with instructions Individuals with severe cardiovascular, respiratory, or neuromuscular diseases for whom exercise loading is medically considered inappropriate Individuals who plan to participate in other interventional studies during the study period Individuals who are otherwise deemed unsuitable for participation in this study by the principal investigator or co-investigators

Design outcomes

Primary

MeasureTime frame
Completion rate of the HAL rehabilitation intervention and incidence of adverse events (including the presence or absence of skin complications at the HAL attachment sites, pain occurrence, and emergence of new neurological symptoms)

Secondary

MeasureTime frame
Active extension angle of the finger metacarpophalangeal (MP) joints, wrist flexion angle during finger MP joint extension, relative surface electromyography (sEMG) amplitude, and the Disabilities of the Arm, Shoulder and Hand (DASH) score

Countries

Japan

Contacts

Public ContactToru Iwahashi

the University of Osaka Graduate School of Medicine Department of Orthopaedic Surgery

kurobuchi0918@ort.med.osaka-u.ac.jp06-6879-3552

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026