Effects of RR and MT on Patient With Stroke

National Taiwan University

Status: Unknown

Conditions: Cerebrovascular Accident

Treatments: Behavioral: Robotic rehabilitation with FES; Behavioral: Mirror Therapy; Behavioral: Robotic Rehabilitation with PI; Behavioral: Robotic Rehabilitation; Behavioral: Conventional Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01655446

201012131RB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing to provide the written informed consent
• More than 6 months onset of unilateral stroke
• An initial 25-56 or 18-50 scores on the UE subtest of the FMA
• Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)
• Without upper limb fracture within 3 months

Exclusion criteria

• Recurrent of stroke or seizure episode during the intervention
• Occurence of serious or continuous pain on affected upper-extremity
• History of other neurological disease or severe orthopaedic condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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100 participants in 5 patient groups, including a placebo group

Robotic Rehabilitation with FES

Experimental group

Description:

Robotic rehabilitation combined Functional Electrical Stimulation (FES)

Treatment:

Behavioral: Robotic rehabilitation with FES

Mirror Therapy

Experimental group

Description:

Mirror Therapy (MT)

Treatment:

Behavioral: Mirror Therapy

Conventional Rehabilitation

Active Comparator group

Description:

Conventional Rehabilitation (CR) mainly focuses on occupational therapy training

Treatment:

Behavioral: Conventional Rehabilitation

Robotic Rehabilitation

Experimental group

Description:

Robotic Rehabilitation (RR)

Treatment:

Behavioral: Robotic Rehabilitation

Robotic Rehabilitation with PI

Placebo Comparator group

Description:

Robotic rehabilitation with Placebo Intervention (RR-PI)

Treatment:

Behavioral: Robotic Rehabilitation with PI