Status:

UNKNOWN

Soft-robotic Glove Support of High-demand Tasks

Lead Sponsor:

Roessingh Research and Development

Conditions:

Neuromuscular Diseases

Sarcopenia

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief Summary

The hand is important to perform activities of daily living (ADL). However, many people experience a loss of hand function as result of a traumatic brain injury, spinal cord injury, stroke or orthoped...

Detailed Description

A promising innovative approach to improve hand function is to integrate exercise therapy with support of activities of daily life using an assistive device. This is possible using a wearable soft-rob...

Eligibility Criteria

Inclusion

  • Frail elderly with reduced hand function:
  • Age between 65 and 90 years
  • Experience difficulties in performing ADL due to a decline in hand function
  • Able to make a pinch grip between thumb and middle or ring finger
  • Sufficient cognitive status to understand two-step instructions
  • Having (corrected to) normal vision
  • Able to provide written informed consent
  • Neuromuscular patients:
  • Age between 18 and 80 years
  • Experience difficulties in performing ADL due to a decline in hand function that can be attributed to a diagnosed neuromuscular disease
  • Being in a chronic and stable phase of disease
  • Able to make a pinch grip between thumb and middle or ring finger
  • Sufficient cognitive status to understand two-step instructions
  • Having (corrected to) normal vision
  • Able to provide written informed consent

Exclusion

  • Frail elderly with reduced hand function:
  • Currently receiving treatment for a disease affecting arm/hand function
  • Used the CarbonHand system in the past 3 months
  • Severe sensory problems of the most-affected hand
  • Severe acute pain of the most-affected hand
  • Wounds on the hands that can provide a problem when using the glove
  • Severe contractures limiting passive range of motion
  • Severe spasticity of the hand (≥2 points on Ashworth Scale)
  • Insufficient knowledge of the Dutch language to understand the purpose or methods of the study
  • Neuromuscular patients:
  • Severe sensory problems of the most-affected hand

Key Trial Info

Start Date :

October 17 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05318638

Start Date

October 17 2022

End Date

December 1 2024

Last Update

September 6 2023

Active Locations (1)

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Roessingh Research and Development

Enschede, Overijssel, Netherlands, 7522AH