Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060492) titled 'Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery' on March 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - the University of Osaka

Condition: Condition - After tendon transfer surgery for upper limb motor dysfunction Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - When motor dysfunction occurs in a specific muscle due to peripheral nerve injury or muscle damage, tendon transfer surgery - an operative procedure in which the tendon of another muscle is rerouted - is considered to restore the impaired motor function. After this surgery, the transferred muscle is required to generate joint movements different from its original function, and central nervous system relearning occurs through rehabilitation to enable efficient execution of the new joint motion. However, in some cases, this relearning process does not progress sufficiently, resulting in suboptimal performance of the intended joint movement. In the present study, we aimed to exploratorily evaluate the safety and feasibility of an intervention using the wearable cyborg Hybrid Assistive Limb (HAL), which has been applied for motor re-education in patients with various neurological disorders, in patients who experience difficulty with functional recovery after tendon transfer surgery. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - 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 caused by wrist movement, a wrist immobilization orthosis is applied and fixed to the table. Subsequently, the medical single-joint type Hybrid Assistive Limb (HAL) is fitted as shown in the right figure. After motion calibration, the assist level and range of motion are individually adjusted according to the participant'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 for MP joint extension detected by the electrode placed over the flexor carpi radialis. In addition, visual feedback is provided by projecting the electromyographic waveform obtained from the electrode over the flexor carpi ulnaris onto a smartphone display. A total of 100 consecutive joint movements are performed per day, followed by post-intervention assessment. The intervention is conducted once every 1 to 2 weeks, with approximately 15 sessions in total.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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 Key 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 Target Size - 2

Recruitment Status: Recruitment status - Terminated Date of protocol fixation - 2026 Year 01 Month 19 Day Date of IRB - 2026 Year 01 Month 19 Day Anticipated trial start date - 2026 Year 03 Month 02 Day Last follow-up date - 2026 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069103

Disclaimer: Curated by HT Syndication.