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Soft Robotic Hand System for Stroke Rehabilitation

Soft Robotic Hand System for Stroke Rehabilitation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03286309
Enrollment
40
Registered
2017-09-18
Start date
2018-04-12
Completion date
2022-07-01
Last updated
2022-05-23

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

Conditions

Stroke

Brief summary

The soft robotic system could provide objective and quantifiable measures of subject performance. By combining voluntary motor intention and the robotic hand technology, the system will facilitate the recovery process of stroke patients.

Interventions

DEVICEsoft robot hand system

subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

1. at chronic stage (6 months after the onset of stroke) with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic); 2. sufficient cognition to follow simple instructions as well as understand the content and purpose of the study; 3. able to sit up for 45 minutes (with or without assistance).

Exclusion criteria

1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication; 2. any additional medical or psychological condition affecting their ability to comply with the study protocol; 3. history of other neurological disease, psychiatric disorder, including alcoholism and substance abuse.

Design outcomes

Primary

MeasureTime frame
Upper limb Fugl Meyer Assessment3-month follow up

Secondary

MeasureTime frameDescription
Action Research Arm Test3-month follow up
Modified Ashworth Scale3-month follow upScale from 0 to 4, whereas 0 is no increase in tone and 4 is limb rigid in flexion or extension
Box and Block Test3-month follow up
Max Voluntary Grip Force3-month follow up

Countries

Hong Kong

Contacts

Primary ContactRaymond Kai-yu Tong, PhD
kytong@cuhk.edu.hk+852 3943 8454

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026