NCT01655446

Effects of RR and MT on Patient With Stroke

Randomized Trials of Robotic Rehabilitation, Mirror Therapy, and Dose-Matched Control Intervention for Upper-Limb Rehabilitation in Patients With Chronic Stroke: Comparative Efficacy and Clinimetric Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Detailed description

Motor deficit of upper extremity is one of the prominent problems in patients with stroke. Looking for effective and efficient treatments to improve affected UE function is of great importance in the field of rehabilitation. Two emerging movement therapies in stroke rehabilitation are robotic rehabilitation (RR) and mirror therapy (MT). Scientific evidence for comparative effectiveness research of RR versus MT versus CI on functional outcomes (e.g., motor, muscle, sensory, and daily functions) in stroke patients is limited. In addition, studies showed FES induced some improvements in individual movements at the shoulder, elbow, wrist, and fingers or in muscle strength in patients with moderate-to-severe paresis. The combination therapy of the FES and training protocols may increase the benefits of standard rehabilitative treatments and may also facilitate motor learning. However, the combined training effects of the RR and FES on stroke patients have not been well studies in a larger sample yet. Specific objectives of this proposed research are as follows: First, The investigators will compare the efficacy of the RR, MT, and conventional rehabilitation. Secondly, the investigators will compare the efficacy of the RR-FES versus RR-PI on outcome measures. Thirdly, the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
BEHAVIORAL	Mirror Therapy	This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
BEHAVIORAL	Conventional Rehabilitation	Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.
BEHAVIORAL	Robotic Rehabilitation	This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
BEHAVIORAL	Robotic rehabilitation with FES	This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
BEHAVIORAL	Robotic Rehabilitation with PI	The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected UL but there is no output of electrical stimulation.

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-08-01
• Last updated: 2012-08-01

Locations

1 site across 1 country: Taiwan