Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: distal robot-assisted therapy; Device: proximal robot-assisted therapy; Behavioral: individualized intensive therapy

• Registration Number: NCT02254343
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

The purpose of this study is to compare the training effects of robot-assisted therapy focus on proximal part, distal part, or total segment of upper extremity, respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-01
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• unilateral stroke that verified by CT scan
• Time since stroke more than 6 months
• moderate and mild upper limb motor impairment identified from the UE subtest of FMA range from 10 to 50
• Mini-Mental State Examination (MMSE) more than 24 points is needed to follow commands

Exclusion Criteria

• serious visual or visual perception problems
• orthopedic or other neurological problems occurred in recent 6 months
• attend any other study in recent 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
distal robot-assisted therapy	distal robot-assisted therapy	the InMotion3 robot system will be used to execute treatment programs focus on wrist movements. It includes three degrees of freedom to allow wrist flexion/extension, abduction/adduction, and pronation/supination.
proximal robot-assisted therapy	proximal robot-assisted therapy	treatment programs will target to shoulder and elbow portions of upper extremity via the InMotion2 robotic system
individualized intensive therapy	individualized intensive therapy	individualized occupational therapy which is dose-match to robot-assisted therapy, based on task-oriented principle.

Primary Outcome Measures

Name	Time	Method
Change scores of Fugl-Meyer assessment(FMA)	baseline, 2 weeks, 4 weeks

Secondary Outcome Measures

Name	Time	Method
Change scores of ABILHAND Questionnaire	baseline, 4 weeks
Change scores of Adelaide Activities Profile (AAP)	baseline, 4 weeks
Change scores of Motor activity log (MAL)	baseline, 4 weeks
Change scores of Accelerometer	baseline, 4 weeks
Change scores of Algometer	baseline, 4 weeks
Change scores of Adverse effects	baseline, 2 weeks, 4 weeks
Change scores of Number stroop test	baseline, 4 weeks
Change scores of kinematic analysis	baseline, 4 weeks
Change scores of Box and block test (BBT)	baseline, 2 weeks, 4 weeks
Change scores of Action research arm test (ARAT)	baseline, 2 weeks, 4 weeks
Change scores of Modified Ashworth scale (MAS)	baseline, 2 weeks, 4 weeks
Change scores of Medical Research Council scale (MRC)	baseline, 2 weeks, 4 weeks
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)	baseline, 4 weeks
Change scores of Functional independent measure (FIM)	baseline, 2 weeks, 4 weeks
Change scores of EuroQol Quality of Life Scale (EQ-5D)	baseline, 4 weeks
Change scores of Hand strength	baseline, 2 weeks, 4 weeks
Change scores of Nottingham Extended ADL Questionnaire (NEADL)	baseline, 4 weeks
Change scores of Wolf Motor Function Test (WMFT)	baseline, 2 weeks, 4 weeks
Change scores of Stroke Impact Scale (SIS 3.0 version)	baseline, 2 weeks, 4 weeks
Change scores of 10-meter walking test	baseline, 4 weeks
Change scores of Montreal Cognitive Assessment (MoCA)	baseline, 4 weeks
Change scores of Myoton	baseline, 4 weeks
Change scores of Revised Nottingham Sensory Assessment (rNSA)	baseline, 4 weeks

Trial Locations

Locations (2)

Chang Gung Memorial Hospital; 🇨🇳 Kwei-Shan, Tao-Yuan, Taiwan

Lo-Sheng Sanatorium and Hospital; 🇨🇳 Kwei-shan, Toayuan county, Taiwan