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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2016
• Main ID: NCT02254343
• Date of registration: 29/09/2014
• Prospective Registration: No
• Primary sponsor: Chang Gung Memorial Hospital
• Public title: Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training
• Scientific title: Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training on Stroke Rehabilitation
• Date of first enrolment: September 2014
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02254343
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Taiwan

Contacts

• Name: Ching-Yi Wu, ScD
• Affiliation: Chang Gung Memorial Hospital

Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Intervention(s)

Device: distal robot-assisted therapy

Device: proximal robot-assisted therapy

Behavioral: individualized intensive therapy

Primary Outcome(s)

Change scores of Fugl-Meyer assessment(FMA) [Time Frame: baseline, 2 weeks, 4 weeks]

Secondary Outcome(s)

Change scores of Action research arm test (ARAT) [Time Frame: baseline, 2 weeks, 4 weeks]

Change scores of Adverse effects [Time Frame: baseline, 2 weeks, 4 weeks]

Change scores of Modified Ashworth scale (MAS) [Time Frame: baseline, 2 weeks, 4 weeks]

Change scores of Motor activity log (MAL) [Time Frame: baseline, 4 weeks]

Change scores of 10-meter walking test [Time Frame: baseline, 4 weeks]

Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) [Time Frame: baseline, 4 weeks]

Change scores of ABILHAND Questionnaire [Time Frame: baseline, 4 weeks]

Change scores of Myoton [Time Frame: baseline, 4 weeks]

Change scores of Accelerometer [Time Frame: baseline, 4 weeks]

Change scores of kinematic analysis [Time Frame: baseline, 4 weeks]

Change scores of Adelaide Activities Profile (AAP) [Time Frame: baseline, 4 weeks]

Change scores of Algometer [Time Frame: baseline, 4 weeks]

Change scores of EuroQol Quality of Life Scale (EQ-5D) [Time Frame: baseline, 4 weeks]

Change scores of Hand strength [Time Frame: baseline, 2 weeks, 4 weeks]

Change scores of Revised Nottingham Sensory Assessment (rNSA) [Time Frame: baseline, 4 weeks]

Change scores of Functional independent measure (FIM) [Time Frame: baseline, 2 weeks, 4 weeks]

Change scores of Box and block test (BBT) [Time Frame: baseline, 2 weeks, 4 weeks]

Change scores of Medical Research Council scale (MRC) [Time Frame: baseline, 2 weeks, 4 weeks]

Change scores of Wolf Motor Function Test (WMFT) [Time Frame: baseline, 2 weeks, 4 weeks]

Change scores of Montreal Cognitive Assessment (MoCA) [Time Frame: baseline, 4 weeks]

Change scores of Nottingham Extended ADL Questionnaire (NEADL) [Time Frame: baseline, 4 weeks]

Change scores of Number stroop test [Time Frame: baseline, 4 weeks]

Change scores of Stroke Impact Scale (SIS 3.0 version) [Time Frame: baseline, 2 weeks, 4 weeks]

Secondary ID(s)

103-3564A3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors