Development of a hand exoskeleton for precise stretch and resistance measurement in hand spasticity assessment

Validation of a novel hand exoskeleton for discriminating hand spasticity levels in post-stroke patients based on stretch-induced resistance

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN84987845

Enrollment

Registered

2024-04-23

Start date

2024-02-01

Completion date

Unknown

Last updated

2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assessment of hand spasticity in adult patients 1 week to 6 months post-stroke, with a Modified Ashworth Scale (MAS) score of 0-3. Nervous System Diseases

Interventions

Initially, participants will be assessed for spasticity using the Modified Ashworth Scale (MAS) by a physiotherapist. Before deploying the device, the researchers will measure the length of each finge

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults who have been medically diagnosed with hand spasticity 2. Participants' dominant hand is assessed as 1 to 3 MAS. 3. Participants should have the cognitive ability to understand the study and provide informed consent, as well as the ability to communicate any discomfort or issues during the study. 4. The capacity to comprehend and adhere to the study's requirements, especially important for interacting with the exoskeleton and providing feedback.

Exclusion criteria

Exclusion criteria: 1. Participants should not experience severe pain in the affected hand that could be aggravated by the use of the exoskeleton. 2. Ensuring there are no medical reasons, such as specific implants or severe deformities, that would contraindicate the use of the hand exoskeleton.

Design outcomes

Primary

Measure	Time frame
1. Hand spasticity measured using the Modified Ashworth Scale (MAS) by a physiotherapist at baseline 2. Features of the experimental data (e.g. mean resistance force) will be identified and used as the variables of hypothesis tests of the difference between healthy people and the spastic participants. 3. All experimental data will also undergo machine learning analysis to ascertain if any discernible patterns or characteristics can effectively discriminate between different levels of hand spasticity, as categorized by the MAS.	—

Measure

Time frame

1. Hand spasticity measured using the Modified Ashworth Scale (MAS) by a physiotherapist at baseline 2. Features of the experimental data (e.g. mean resistance force) will be identified and used as the variables of hypothesis tests of the difference between healthy people and the spastic participants. 3. All experimental data will also undergo machine learning analysis to ascertain if any discernible patterns or characteristics can effectively discriminate between different levels of hand spasticity, as categorized by the MAS.

—

Secondary

Measure	Time frame
The usability of the device and user experience will be evaluated with questionnaires based on the System Usability Scale at [timepoint]	—

Countries

Scotland, United Kingdom

Contacts

Public ContactHao Yu

hy2020@hw.ac.uk+44 (0)7556713984

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026