MedDataX Logo

Differential Effectiveness of Robotic Assisted Therapy on Upper Extremity Function in Patients With Chronic Stroke

NCT ID: NCT04260061

Last Updated: 2020-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-19

Study Completion Date

2020-01-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objectives of this study are to: determine the effects of exoskeleton vs. end effector training systems on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in patients with chronic stroke.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

According to the theory and literature review, there are two hypotheses in this study. One is that exoskeleton training system has better benefits than end-effector training system in motion control techniques, joint mobility and muscle tone control. Second, end-effector training system has better benefits than exoskeleton training system in the functional activity level and daily life participation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

exoskeleton group

The Hand of Hope therapy device will be used in this group. The hand brace is worn on the dorsal side of the impaired hand with 2 surface sensors attached to the extensor and flexor muscles of the arm to detect the surface electromyographic signals (sEMG) for active participation during exercise. The sEMG signals are processed so the patient can visualise the active movement of the muscle where sEMG electrodes are positioned. Different training modes allow the therapist to customise the level of assistance that the Hand of Hope provides. The difficulty level of each mode can be adjusted according to the patient's need.

Group Type EXPERIMENTAL

training systems

Intervention Type DEVICE

Participants will receive 18 intervention sessions for about 6-9 consecutive weeks in a clinical setting (75 minutes per session, 2-3 sessions per week). For each intervention session, participants will first receive 10 minutes of warm-up followed by 50 minutes robotic-assisted training (robotic-assisted training includes 10 minutes passive training mode, 20 minutes active training mode, and 20 minutes robot-participant interactive training mode) and then 15 minutes of functional activity without robotic-assisted (content will be related to robotic-assisted training and will be based on the action function and preferences of the participants).

end effector group

The Amadeo Hand-Therapy-System will be used in this group. The Amadeo is a mechatronic rehabilitation device that allows each individual finger to move independently and separately. The main target group are patients suffering from functional motor disabilities of the distal upper extremity. The Amadeo consists of the electrically driven moment mechanism, a supportive framework which is adjustable in height and includes a hand-arm support, and a control and operating unit (all-in-one PC). The finger slides can produce flexion/extension movement of the fingers and the thumb. The fingers and the thumb of the affected hand are attached to the slides and then passive, assistive, active or interactive therapy regime can be started. The integrated sensors for force and position measurement enable quantitative recording and evaluation of the finger range of movement and force.

Group Type EXPERIMENTAL

training systems

Intervention Type DEVICE

Participants will receive 18 intervention sessions for about 6-9 consecutive weeks in a clinical setting (75 minutes per session, 2-3 sessions per week). For each intervention session, participants will first receive 10 minutes of warm-up followed by 50 minutes robotic-assisted training (robotic-assisted training includes 10 minutes passive training mode, 20 minutes active training mode, and 20 minutes robot-participant interactive training mode) and then 15 minutes of functional activity without robotic-assisted (content will be related to robotic-assisted training and will be based on the action function and preferences of the participants).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

training systems

Participants will receive 18 intervention sessions for about 6-9 consecutive weeks in a clinical setting (75 minutes per session, 2-3 sessions per week). For each intervention session, participants will first receive 10 minutes of warm-up followed by 50 minutes robotic-assisted training (robotic-assisted training includes 10 minutes passive training mode, 20 minutes active training mode, and 20 minutes robot-participant interactive training mode) and then 15 minutes of functional activity without robotic-assisted (content will be related to robotic-assisted training and will be based on the action function and preferences of the participants).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic Stroke more than 3 months.
* FMA score 29\~59.
* Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
* Mini Mental State Examination ≥ 24 and no serious cognitive impairment.
* Learn more about the research content and can provide informed consent.

Exclusion Criteria

* Other neurological disease
* Inability to understand instructions
* current participation in any other research
* Botulinum Toxin injection within 3 months
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ching-yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

201900904A3

Identifier Type: -

Identifier Source: org_study_id