UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060492 |
|---|---|
| Receipt number | R000069103 |
| Scientific Title | Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/26 19:50:24 |
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Basic information
Public title
Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery
Acronym
Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery
Scientific Title
Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery
Scientific Title:Acronym
Exploratory pilot study on the safety and feasibility of single-joint HAL-assisted motor re-education in patients after upper limb tendon transfer surgery
Region
| Japan |
Condition
Condition
After tendon transfer surgery for upper limb motor dysfunction
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Iwahashi |
Organization
the University of Osaka Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka, Japan
TEL
06-6879-3552
kurobuchi0918@ort.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Iwahashi |
Organization
the University of Osaka Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka, Japan
TEL
06-6879-3552
Homepage URL
kurobuchi0918@ort.med.osaka-u.ac.jp
Sponsor or person
Institute
the University of Osaka
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Interventional Studies, University Hospital, Faculty of Medicine
Address
2-2 Yamadaoka, Suita-shi, Osaka, Japan
Tel
06-6879-3077
coi-med@office.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069103
