Clinical trial NCT02254343: Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training
Official title: Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training on Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke rehabilitation
robot-assisted therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change scores of Fugl-Meyer assessment(FMA)
timeFrame: baseline, 2 weeks, 4 weeks
Secondary outcomes:
measure: Change scores of Box and block test (BBT)
timeFrame: baseline, 2 weeks, 4 weeks
measure: Change scores of Action research arm test (ARAT)
timeFrame: baseline, 2 weeks, 4 weeks
measure: Change scores of Medical Research Council scale (MRC)
timeFrame: baseline, 2 weeks, 4 weeks
measure: Change scores of Modified Ashworth scale (MAS)
timeFrame: baseline, 2 weeks, 4 weeks
measure: Change scores of Myoton
timeFrame: baseline, 4 weeks
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: baseline, 2 weeks, 4 weeks
measure: Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: baseline, 4 weeks
measure: Change scores of Functional independent measure (FIM)
timeFrame: baseline, 2 weeks, 4 weeks
measure: Change scores of Stroke Impact Scale (SIS 3.0 version)
timeFrame: baseline, 2 weeks, 4 weeks
measure: Change scores of EuroQol Quality of Life Scale (EQ-5D)
timeFrame: baseline, 4 weeks
measure: Change scores of Hand strength
timeFrame: baseline, 2 weeks, 4 weeks
measure: Change scores of Motor activity log (MAL)
timeFrame: baseline, 4 weeks
measure: Change scores of ABILHAND Questionnaire
timeFrame: baseline, 4 weeks
measure: Change scores of 10-meter walking test
timeFrame: baseline, 4 weeks
measure: Change scores of Nottingham Extended ADL Questionnaire (NEADL)
timeFrame: baseline, 4 weeks
measure: Change scores of Adelaide Activities Profile (AAP)
timeFrame: baseline, 4 weeks
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: baseline, 4 weeks
measure: Change scores of Number stroop test
timeFrame: baseline, 4 weeks
measure: Change scores of Accelerometer
timeFrame: baseline, 4 weeks
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
timeFrame: baseline, 4 weeks
measure: Change scores of Algometer
timeFrame: baseline, 4 weeks
measure: Change scores of kinematic analysis
timeFrame: baseline, 4 weeks
measure: Change scores of Adverse effects
timeFrame: baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Kwei-Shan, Tao-Yuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: Kwei-shan, Toayuan county
country: Taiwan
facility: Lo-Sheng Sanatorium and Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-Yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: