Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 582 for:    Recruiting, Not yet recruiting, Available Studies | Superior

Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03752775
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Xiaoling Hu, The Hong Kong Polytechnic University

Brief Summary:
A new clothing robotic arm was developed for multi-joint coordinated upper limb rehabilitation after stroke. Patients after stroke will be recruited to evaluate the rehabilitation effectiveness of the device assisted upper limb rehabilitation. Both patients with chronic stroke and subacute stroke will be investigated.

Condition or disease Intervention/treatment Phase
Upper Limb Rehabilitation Device: Robot assisted upper limb rehabilitation Not Applicable

Detailed Description:

A new robotic arm, named mobile exo-neuro-musculo-skeleton, was developed for upper limb rehabilitation. The system integrated the advantages of exoskeleton, soft robot, and neuromuscular electrical stimulation. It is noninvasive, light in weight, comfortable to wear, and can support the motions at the elbow, the wrist and the fingers. The device is a mobile system interfaced with a mobile app by a user.

The device assisted upper limb rehabilitation will be applied to inpatients with subacute stroke. The rehabilitation effects on the motor restoration in the upper limb will be compared with the conventional physical and occupational therapies. The rehabilitation effects of the device assisted training also will be evaluated on patients with chronic stroke. The motor improvements after training will be investigated by comparing the pre- and post- clinical assessments. It is hypothesized that the device assisted upper limb rehabilitation will be effective in both subacute and chronic patients.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The device assisted treatment will be administrated to patients with subacute stroke and chronic stroke. The subacute stroke group will be compared in parallel with a control group receive the conventional physical and occupational therapies.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mobile Electromyography (EMG)-Driven Exoneuromusculoskeleton for Upper Limb Rehabilitation After Stroke
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: subacute device assisted group Device: Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.

Active Comparator: subacute conventional group Device: Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.

chronic device assisted group Device: Robot assisted upper limb rehabilitation
The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.




Primary Outcome Measures :
  1. Fugl-Meyer Assessment (FMA) of the Upper Limb before the training [ Time Frame: For each subject, the FMA score will be measured one day before the training. ]
  2. Fugl-Meyer Assessment (FMA) of the Upper Limb after the training [ Time Frame: For each subject, the FMA score will be measured one day after the 20-session training program. ]
  3. Fugl-Meyer Assessment (FMA) of the Upper Limb 3-month follow-up [ Time Frame: For each subject, the FMA score will be measured 3 months later after the last day of the training. ]

Secondary Outcome Measures :
  1. Modified Ashworth Scale (MAS) [ Time Frame: For each subject, the MAS score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training. ]
  2. Action Research Arm Test (ARAT) [ Time Frame: For each subject, the ARAT score will be measure one day before the training, one day after the 20-session training program, and 3 months later after the last day of the training. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For the subacute groups:

  • Two weeks after the onset of stroke, however less than 0.5 year
  • Mini-Mental State Examination (MMSE)>21
  • Able to sit up for at least 1 hour
  • Fugl-Meyer Assessment (FMA) upper limb <30
  • Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
  • Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)

For the chronic device assisted group:

  • At least 0.5 year after the onset of stroke
  • Mini-Mental State Examination (MMSE)>21
  • Able to sit up for at least 1 hour
  • Fugl-Meyer Assessment (FMA) upper limb <30
  • Modified Ashworth Score (MAS) at the elbow, wrist and fingers <3
  • Detectable EMG on the target driving muscles (i.e., 3 times of the standard deviation above the baseline)

Exclusion Criteria:

Subjects will be excluded if they do not meet the above inclusion criteria, or had the following conditions:

  • Currently pregnant
  • Dysphasia (language deficiency)
  • Post-stroke neglect
  • Pacemaker implantation,
  • Involved in drug studies, other clinical trials, or concurrent medication/occupational/physical treatments on the upper limb
  • The overall medical condition not suitable for the training (e.g., severe cardiac problem, unstable blood pressure, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752775


Contacts
Layout table for location contacts
Contact: Xiaoling Hu, PhD 34003206 xiaoling.hu@polyu.edu.hk

Locations
Layout table for location information
China
The Hong Kong Polytechnic University Recruiting
Hong Kong, China
Contact: Xiaoling Hu, Ph.D.    +852 34003205    xiaoling.hu@polyu.edu.hk   
Principal Investigator: Xiaoling Hu, Ph.D.         
Sponsors and Collaborators
The Hong Kong Polytechnic University

Layout table for additonal information
Responsible Party: Xiaoling Hu, Principal Investigator, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03752775     History of Changes
Other Study ID Numbers: ITS/073/16
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaoling Hu, The Hong Kong Polytechnic University:
stroke
upper limb
Joint coordination

Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases