An Exploratory Study of a Wearable Robotic Hand Orthosis

NCT06412237 | Recruiting

• 1 other identifier: DSRB2023/00448
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Hand exoskeleton robot; Robotic hand orthosis

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test (ARAT) Score

  Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.

  Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

Secondary Outcomes (7)

• Fugl-Meyer Motor Assessment (FMA) scale

  Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

• Grip Strength (kg)

  Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

• Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)

  Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

• EQ-5D-5L scale

  Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

• Self-efficacy outcomes by UPSET (upper limb self-efficacy test)

  Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

Other Outcomes (2)

• Modified Ashworth Scale (MAS)

  Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

• Visual Analogue Scale (self-reported pain score)

  Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)

Study Arms (1)

RELab tenoexo

EXPERIMENTAL

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.

Device: RELab tenoexo

Interventions

RELab tenoexo DEVICE

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

RELab tenoexo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 40842028 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tegan Plunkett

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Megan Lau

CONTACT

68894580; megan_se_lau@ttsh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, pilot, feasibility study that focuses on the transition of technology use from the clinic to home environment.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 14, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)