Comparative Efficacy Research of Robot-Assisted Therapy With and Without Constraint-Induced Therapy in Stroke Rehabilitation
Cerebrovascular Accident
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring comparative efficacy research, combination therapy, neurorehabilitation, robot-assisted therapy, constraint-induced therapy
Eligibility Criteria
Inclusion Criteria:
- 6 months onset from a first-ever unilateral stroke
- an initial UL subsection of the Fugl-Meyer Assessment score of 20 to 56
- minimal motor criteria to receive CIT (i.e., ≥ 100 wrist extension and ≥ 100 extension at the thumb and any two other digits)
- no excessive spasticity in any of the joints of the affected UL (modified Ashworth scale ≤ 3)
- without upper limb fracture within 3 months
- be able to follow study instructions and perform study tasks (Mini Mental State Examination ≥ 24)
- welling to provide written informed consent
Exclusion Criteria:
- physician-determined major medical problems or poor physical conditions that would interfere with participation
- excessive pain in any joint that might limit participation
Sites / Locations
- Buddhist Tzu Chi General Hospital Taipei Branch
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Experimental
Distributed constraint-induced therapy (dCIT)
Robot-assisted therapy (RT)
Dose-matched control therapy (DMCT)
RT + dCIT
The dCIT group will focus on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected UL in functional tasks for 1.5 hours/weekday over the 4 weeks.
The ArmeoSpring (Hocoma AG, Switzerland) will be adopted in this study. It is a 5 degree-of-freedom skeleton mechanism that automates arm movement in a gravity-supported and computer-enhanced environment. The design of the arm support component of the ArmeoSpring is based on Wilmington Robotic Exoskeleton, an antigravity arm support. The ArmeoSpring g provides weight support for the arm across a large 3D workspace, enabling naturalistic movement across approximately 66% of the normal workspace in the vertical plane and 72% in the horizontal plane. Its main structure consists of an arm exoskeleton with elastic bands that relieve the weight of the limb and provide a sense of arm flotation at all positions in the available workspace. A custom grip sensor consisting of a water-filled cylindrical bladder detects grip pressure and finger movement and allows incorporation of grasp and release practice into arm training.
The DMCT group mediated by the therapists will be designed to control for the duration of therapy in amount of therapy hours. This group will received a structured protocol using conventional occupational therapy techniques such as neuro-developmental techniques with emphasis on functional tasks and muscle strengthening.
In this combination therapy group, the participants will received 2 weeks of RT using the ArmeoSpring and followed by 2 weeks of distributed CIT. The treatment principles of RT and distributed CIT are the same with those described in the monotherapy of RT or dCIT, respectively. This combined intervention group may integrate proximal (shoulder and elbow) to distal (wrist and hand) training of the UL and help transfer from motor ability gained to functional performance improvement. That is, it appears to associate with the advantages/effects of each RT and dCIT intervention.