Clinical trial NCT04436627: Protocol Design of Hand Robotics Assisted Therapy in Patients With Different Severity of Stroke
Official title: Protocol Design of Hand Robotics Assisted Therapy in Patients With Different Severity of Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Robotic Training
Neurorehabilitation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Some studies have shown that the end-effector type of hand robotic-assisted therapy (RT) can effectively improve upper extremity (UE) motor function in patients with stroke. However, these studies provide insufficient information on treatment protocol, making it difficult for therapists to apply the RT in clinical practice. This study aims to develop an end-effector RT treatment protocol and to examine the preliminary effects of the treatment protocol on UE motor function in patients with stroke.

Detailed description: There are two objectives in this case series study. One is combining external scientific evidence with clinical expertise to design a detailed training protocol for RT in patients with different severity of stroke. The other is to examine the effects on UE motor function and explore the client perspective.

The training protocol was developed based on the ACE Star Cycle Knowledge Transformation Model, which includes steps such as summarizing previous evidence and adjusting the protocol after practice by therapists. Purposive sampling will be used to recruit 35patients with stroke with different severities (Brunnstrom stage of distal part: 10 for stage II\~III /10 for stage IV /15 for stage V\~VI) from a regional hospital in Taiwan. Each participant will receive 12-15 sessions of 50-60 minutes intervention over 3 weeks. Motor function evaluations will be administered before and after the intervention. Wilcoxon Signed Rank test will be used to examine the change between the pretest and posttest.

Eligibility criteria: Inclusion Criteria:

* (1) Unilateral stroke patients diagnosed by neurologists with stable life conditions
* (2) Twenty years old or older
* (3) Modified Ashworth Scale of proximal UE ≤ 3 (shoulder and elbow), and Modified Ashworth Scale of distal UE ≤ 2 (wrist and fingers)
* (4) UE subscale of Fugl-Meyer Assessment score \< 60
* (5) Cognitive test with the Mini Mental State Examination ≥ 21
* (6) Can provide informed consent

Exclusion Criteria:

* (1) Joint contracture greater than 10° in the paretic wrist or hand
* (2) Absence of proprioception in the wrist and hand
* (3) Other neurological or psychological disorders, e.g. Parkinson's disease
* (4) Receiving Botulinum toxin injections within 3 months
* (5) Enrolling in other rehabilitation experiments or drug studies within 3 months
* (6) unable to operate the AMADEO training system or who may have safety concern

Primary outcomes:
measure: Fugl-Meyer Assessment, FMA
timeFrame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
measure: Modified Ashworth scale of muscle spasticity, MAS
timeFrame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
measure: Grip and pinch power
timeFrame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
measure: Medical Research Council scale, MRC
timeFrame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
measure: Wolf Motor Function Test, WMFT
timeFrame: Frame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
measure: Nine-hole pegboard test, NPT
timeFrame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
measure: User experience
timeFrame: Baseline, post test immediately after completing 12-15 intervention sessions (around 3 weeks after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: