Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
NCT06412237

An Exploratory Study of a Wearable Robotic Hand Orthosis

Led by Tan Tock Seng Hospital · Updated on 2025-04-15

20

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

An Exploratory Study of a Wearable Robotic Hand Orthosis

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • First-ever clinical stroke (ischemic or hemorrhagic) with hemiplegic motor deficits confirmed by CT or MRI
  • At least 6 months post-stroke with stable neurological condition
  • Age between 21 and 80 years
  • Hemiplegic pattern with shoulder abduction and elbow extension motor power greater than 2/5
  • Stable home environment with a caregiver or next of kin to help with device use and supervise exercises at home
  • Montreal Cognitive Assessment (MOCA) score of 22 or higher out of 30
  • Able to provide informed consent at the research site
  • Able to communicate in English
Not Eligible

You will not qualify if you...

  • Arm motor impairments caused by conditions other than stroke
  • Unstable or terminal medical conditions affecting participation (e.g., unresolved infections, severe blood pressure issues, end-stage kidney failure, cancer, HIV, immunosuppression) or life expectancy less than 1 year due to serious illness
  • Local arm issues worsened by intensive therapy such as severe spasticity, skin wounds, high shoulder pain, fractures, arthritis, or fixed joint/tissue contractures incompatible with the device
  • Severe cognitive, perceptual, or emotional-behavioral problems preventing participation
  • Moderate to severe pain levels above 5 on a pain scale
  • Pregnant or breastfeeding women
  • Presence of a pacemaker due to device magnets

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tan Tock Seng Hospital

Singapore, Singapore, Singapore

Actively Recruiting

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Research Team

M

Megan Lau

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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