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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254343
• Other study ID #: 103-3564A3
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: September 14, 2016
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• proximal robot-assisted therapy

• distal robot-assisted therapy

Behavioral:
• individualized intensive therapy

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Kwei-Shan, Tao-Yuan
Taiwan	Lo-Sheng Sanatorium and Hospital	Kwei-shan, Toayuan county

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores of Fugl-Meyer assessment(FMA)		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of Box and block test (BBT)		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of Action research arm test (ARAT)		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of Medical Research Council scale (MRC)		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of Modified Ashworth scale (MAS)		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of Myoton		baseline, 4 weeks	No
Secondary	Change scores of Wolf Motor Function Test (WMFT)		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)		baseline, 4 weeks	No
Secondary	Change scores of Functional independent measure (FIM)		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of Stroke Impact Scale (SIS 3.0 version)		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of EuroQol Quality of Life Scale (EQ-5D)		baseline, 4 weeks	No
Secondary	Change scores of Hand strength		baseline, 2 weeks, 4 weeks	No
Secondary	Change scores of Motor activity log (MAL)		baseline, 4 weeks	No
Secondary	Change scores of ABILHAND Questionnaire		baseline, 4 weeks	No
Secondary	Change scores of 10-meter walking test		baseline, 4 weeks	No
Secondary	Change scores of Nottingham Extended ADL Questionnaire (NEADL)		baseline, 4 weeks	No
Secondary	Change scores of Adelaide Activities Profile (AAP)		baseline, 4 weeks	No
Secondary	Change scores of Montreal Cognitive Assessment (MoCA)		baseline, 4 weeks	No
Secondary	Change scores of Number stroop test		baseline, 4 weeks	No
Secondary	Change scores of Accelerometer		baseline, 4 weeks	No
Secondary	Change scores of Revised Nottingham Sensory Assessment (rNSA)		baseline, 4 weeks	No
Secondary	Change scores of Algometer		baseline, 4 weeks	No
Secondary	Change scores of kinematic analysis		baseline, 4 weeks	No
Secondary	Change scores of Adverse effects		baseline, 2 weeks, 4 weeks	Yes