Robot-Assisted Therapy in Stroke Patients

Stroke Clinical Trial

Official title:

Robot-Assisted Upper Limb Rehabilitation in Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00917605
• Other study ID #: 200903080R
• Status: Recruiting
• Phase: N/A
• First received: June 8, 2009
• Last updated: July 8, 2012
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2012
• Source: National Taiwan University Hospital
• Contact: Keh-chung Lin, ScD
• Phone: 886-2-33668180
• Email: kehchunglin[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

This project consists of two parts: Robotic Rehabilitation Trials, and Study of Outcome Predictors and Clinimetric Attributes. In the first part of study, the investigators aim to (1) investigate the treatment effects of robot-assisted therapy (RAT) in patients with stroke on various outcomes, (2) test the dose-response relations by using two different intensities (higher versus lower intensity RAT), and (3) investigate the effects of the training intensity on a biomarker of oxidative stress. Treatment outcomes will encompass the spectrum of functioning including motor ability, motor control strategies, basic/extended daily functions, mobility, community reintegration, quality of life, and biomarker (8-OHdG). In the second part of study, the purposes are to define the appropriate populations for RAT and to examine the clinimetric properties of clinical measures relevant for use in robotic rehabilitation research. the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions. Finally, the investigators will examine and compare the clinimetric properties (e.g., validity and responsiveness) of the clinical measures of rehabilitation outcome to inform selection of test instruments that may detect clinically meaningful change after rehabilitation therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 3 to 24 months onset from a first-ever unilateral stroke

2. an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment

3. no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers)

4. be able to follow study instructions and perform study tasks

5. without upper limb fracture within 3 months

6. lack of participation in any experimental rehabilitation or drug studies during the study period

7. willing to provide written informed consent

Exclusion Criteria:

1. subjects exhibiting physician-determined major medical problems or poor physical conditions that would interfere with participation

2. subjects with excessive pain in any joint that might limit participation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accidents
• Stroke

Intervention

Other:
• Robot-assisted therapy
Patients will receive an intervention for 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). The Robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany), will be used in this project. The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns: forearm pronation-supination and wrist flexion-extension (Hesse et al., 2003; Hesse et al., 2005). Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. Mode 3 is an active mode as in 2, but the paretic arm had to overcome an individually set, initially isometric resistance to allow the bilateral movement. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer Assessment		before and after intervention	No