An Exploratory Study of a Wearable Robotic Hand Orthosis

NCT ID: NCT06412237

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-01-31

Brief Summary

Upper limb deficits usually remain in 75% of the stroke survivors despite completing full rehabilitation. This is due to lack of effectiveness of rehabilitation and the degree of support and resources available.

In this study, the investigators plan to study the use of assistive technologies in chronic stroke survivors.

Detailed Description

Assistive technologies have shown promising results in immediate improvement in functional abilities.

RELab tenoexo is a fully wearable and portable robotic hand orthoses (RHO) used for functional training. Its design support end users with functional hand opening and closing and can be applied in therapy exercises or during functional activities. While prior research demonstrated its effectiveness for spinal cord injury, it hasn't been tailored for multi-ethnic stroke populations.

This study aims to determine the feasibility and extent to which the RELab tenoexo can complement therapy training in clinic and further be used as both a training and assistive device in the home environment. In addition, it also aims to investigate the amount of upper limb usage before, during and after the training period.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RELab tenoexo

3 weeks in clinic training (9 training sessions, two clinical assessment and 2 usability evaluations) followed by 2 weeks home training (1-hour daily training and to the extent participants desire). Lastly 1-month follow up clinical assessment and IMU data collection.

Group Type: EXPERIMENTAL

RELab tenoexo

Intervention Type: DEVICE

The RELab tenoexo is a fully wearable and portable RHO developed at the Rehabilitation Engineering Laboratory (RELab) at ETH Zurich.

Interventions

RELab tenoexo

The RELab tenoexo is a fully wearable and portable RHO developed at the Rehabilitation Engineering Laboratory (RELab) at ETH Zurich.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient with first ever clinical stroke (ischaemic or haemorrhagic) with hemiplegic motor deficit(s) due to stroke as diagnosed by CT or MRI.
• Post stroke of at least 6 months with stable neurological status.
• Age 21 to 80 years of age.
• Hemiplegic pattern and shoulder abduction MRC motor power > 2/5 and elbow extension >2/5
• Has a stable home abode and a carer/NOK to assist with donning of device and supervise home based exercise
• MOCA > or equal to 22/30
• Able to give and sign informed consent at research site.
• Able to speak English

Exclusion Criteria

• Non-stroke related causes of arm motor impairment.
• Has unstable or terminal medical conditions which may affect participation (e.g.: unresolved sepsis, postural hypotension, end stage renal failure, cancer, retroviral disease, on immunosuppressive therapy) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder.
• Local factors which may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain Pain Scale >5/10, active/non-united fractures or arthritis or fixed joint/tissue flexion contractures of shoulder, elbow, wrist or fingers incompatible with tenoexo interface.
• Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation.
• Experiencing moderate to severe levels of pain (Numerical Vertical Pain Scale > 5).
• Is pregnant or breast feeding. Neither the tenoexo nor the IMUs have been tested to evaluate the usage with pregnant and/or breast feeding mothers. Further, due to the length of the study, pregnancy may make it difficult to follow the study schedule.
• Have a pacemaker. Magnets are used throughout the system.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tegan Plunkett

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

Tan Tock Seng Hospital

Singapore, Singapore, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Megan Lau

Role: CONTACT

megan_se_lau@ttsh.com.sg

68894580

Facility Contacts

Megan Lau

Role: primary

Megan_SE_Lau@ttsh.com.sg

References

Tanczak N, Plunkett TK, Lin S, Kuenzler L, Lau M, Kuah WKC, Ng CY, Gassert R, Chua K, Lambercy O. Feasibility of post-stroke hand rehabilitation supported by a soft robotic hand orthosis in-clinic and at-home. J Neuroeng Rehabil. 2025 Aug 21;22(1):183. doi: 10.1186/s12984-025-01717-6.

Reference Type: DERIVED

PMID: 40842028 (View on PubMed)

Other Identifiers

DSRB2023/00448

Identifier Type: -

Identifier Source: org_study_id