Interactive Intention-Driven Upper-Limb Training Robotic System

NCT02077439 | Completed DMC

• 1 other identifier: ITT/004/12GP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.

Conditions

Stroke

Keywords

Stroke; Hand; Upper Extremity; Robotics

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment

  Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.

  Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months

• Action Research Arm Test

  Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention.

  Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months

Secondary Outcomes (2)

• Wolf Motor Function Test

  Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months

• modified Ashworth Scale

  Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months

Study Arms (3)

Hand Robotic Training

EXPERIMENTAL

Hand Robotic Training

Device: Hand Robotic Training

Hand and Arm Robotic Training

EXPERIMENTAL

Hand and Arm Robotic Training

Device: Hand and Arm Robotic Training

Conventional therapy

ACTIVE COMPARATOR

Conventional therapy

Other: Conventional therapy

Interventions

Hand Robotic Training DEVICE

Training for 20 sessions for one hour, 3-5 times per week.

Hand Robotic Training

Hand and Arm Robotic Training DEVICE

Training for 20 sessions for one hour, 3-5 times per week.

Hand and Arm Robotic Training

Conventional therapy OTHER

Training for 20 sessions for one hour, 3-5 times per week.

Conventional therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

You may not qualify if:

• Excessive spasticity of the affected arm
• Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Links

• The Hong Kong Polytechnic University

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raymond KY Tong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: January 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2016
• Last Updated: February 24, 2017

Record last verified: 2017-02

Locations

HK (1)