Clinical trial NCT02451280: Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation
Official title: Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke rehabilitation
robot-assisted therapy
hybrid therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-05-21
Enrollment: 72
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 aim of the project is to compare the effects of unilateral hybrid therapy \[unilateral robot-assisted therapy (RT)\] + unilateral arm training (UAT)\] and bilateral hybrid therapy \[bilateral RT + bilateral arm training (BAT)\] on motor function, daily function, mobility, life quality, and motor control strategy in stroke patients.


Eligibility criteria: Inclusion Criteria:

1. ≥3 months onset from a first-ever unilateral stroke;
2. minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits);
3. an initial FMA-UE score of 10 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment;
4. no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers);
5. able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 22);
6. without upper extremity fracture within 3 months;
7. no participation in any rehabilitation experiments or drug studies during the study period; and (8) willing to provide written informed consent.

Exclusion Criteria:

1. acute inflammatory disease;
2. major health problems or poor physical condition that might limit participation; and (3) attend any other study in recent 3 months.

Primary outcomes:
measure: Change scores of Fugl-Meyer assessment(FMA)
timeFrame: baseline, 3 weeks, 6 weeks, 18 weeks
Secondary outcomes:
measure: Wolf Motor Function Test (WMFT)
timeFrame: baseline, 6 weeks
measure: Change scores of Box and block test (BBT)
timeFrame: baseline, 3 weeks, 6 weeks, 18 weeks
measure: Change scores of Action research arm test (ARAT)
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change scores of Medical Research Council scale (MRC)
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change scores of Modified Ashworth scale (MAS)
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change scores of Myoton
timeFrame: baseline, 6 weeks
measure: Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: baseline, 6 weeks
measure: Change scores of Functional independent measure (FIM)
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change scores of Stroke Impact Scale (SIS 3.0 version)
timeFrame: baseline, 3 weeks, 6 weeks, 18 weeks
measure: Change scores of EuroQol Quality of Life Scale (EQ-5D)
timeFrame: baseline, 6 weeks
measure: Change scores of Hand strength
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change scores of Motor activity log (MAL)
timeFrame: baseline, 6 weeks, 18 weeks
measure: Change scores of ABILHAND Questionnaire
timeFrame: baseline, 6 weeks, 18 weeks
measure: Change scores of 10-meter walking test
timeFrame: baseline, 6 weeks
measure: Change scores of Nottingham Extended ADL Questionnaire (NEADL)
timeFrame: baseline, 6 weeks, 18 weeks
measure: Change scores of Adelaide Activities Profile (AAP)
timeFrame: baseline, 6 weeks
measure: Change scores of Accelerometer
timeFrame: baseline, 6 weeks
measure: Change scores of kinematic analysis
timeFrame: baseline, 6 weeks
measure: Change scores of Adverse effects
timeFrame: baseline, 3 weeks, 6 weeks
measure: Change scores of Algometer
timeFrame: baseline, 6 weeks
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
timeFrame: baseline, 6 weeks
Other outcomes:
Locations:
city: Kwei-shan
country: Taiwan
facility: Lo-Sheng Sanatorium and Hospital
state: Toayuan county
city: Kwei-Shan, Tao-Yuan
country: Taiwan
facility: Chang Gung Memorial Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-Yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hung CS, Lin KC, Chang WY, Huang WC, Chang YJ, Chen CL, Grace Yao K, Lee YY. Unilateral vs Bilateral Hybrid Approaches for Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Dec;100(12):2225-2232. doi: 10.1016/j.apmr.2019.06.021. Epub 2019 Aug 14.