Clinical trial NCT04393480: Upper Extremity Robotic Rehabilitation in Patients With Hemiplegia
Official title: Comparison of Upper Extremity Robotic Rehabilitation Efficiency With Conventional Rehabilitation in Patients With Hemiplegia After Cerebrovascular Event
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia and/or Hemiparesis Following Stroke
Keywords: robotic therapy
rehabilitation
upper extremity
cerebrovascular event
stroke
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of Upper Extremity Robotic Rehabilitation Efficiency with Conventional Rehabilitation in Patients with Hemiplegia after Cerebrovascular Event

Detailed description: The aim of this single-blind randomized prospective study is to find out whether including robotic therapy in addition to conventional rehabilitation program has an effect on quality of life, motor function and activities of daily living of the hemiplegic patients. Hemiplegic patients diagnosed by anamnesis, physical examination and radiological analysis, which have been referred to the outpatient clinic of Ege University Faculty of Medicine Department of Physical Therapy and Rehabilitation between April 2016 and April 2019 have been taken to the study. The demographic and clinical data of the patients were recorded and they were randomized into 2 groups. 17 patients assigned to the robotic rehabilitation group (Study group) receiving robot-assisted rehabilitation in addition to conventional treatment and 20 assigned to the conventional rehabilitation group (control group) receiving only conventional therapy completed the study. Robotic-based rehabilitation given additionally was arranged to be 30-45 minutes, 5 days per week for 4 weeks. All patients were assessed at the beginning of therapy and at the end of 4th week with Brunnstrom stages of motor recovery, Fugl Meyer Assessment (FMA), hand grip strength, Purdue peg test, Minnesota manual dexterity test, Modified Ashworth Scale (MAS) , Functional Independance Measure (FIM), Stroke Specific Quality of Life Scale (SS-QOL), Nottingham Extended Activities of Daily Living (NEADL) Scale, Montreal Cognitive Assessment (MoCA), Center for Epidemiological Studies Depression Scale (CES- D). In the study, improvements in motor function scores, spasticity, general functioning, activities of daily living, cognitive assessment scale are better in robotic group when compared with control group but this difference was not statistically significant (p\>0,05). The investigators have found statistically significant improvement in CES- Depression scale in robotic group compared with control group (p=0,018). Significantly improved motor function gains are observed before and after the treatment in both groups being better in the robotic group however no significant differences were observed between the groups after the treatment. Robotic rehabilitation provides a favorable alternative bringing slight benefits, and also advantageous in terms of work power and psychological recovery so robotic rehabilitation addition to conventional neurological rehabilitation is effective and useful in patient management after stroke or cerebrovascular events.

Eligibility criteria: Inclusion Criteria:

* Having a single stroke
* Being an adult
* Having a duration of 4 to 30 months after stroke
* A score greater than 16 in mini-mental test
* Upper extremity Brunnstrom stage 2 or higher
* Being a fluent speaker in Turkish.

Exclusion Criteria:

* Severe apraxia
* Skin ulcers
* Multiple cerebrovascular events
* Severe decompensated diseases (cardiopulmonary, neurological, orthopedic and psychiatric etc), cardiac pacemakers, severe neuropsychological impairment,
* Neglect syndrome
* Spasticity greater than 3 in Modified Ashworth Scale
* Severe joint contractures
* Botulinum toxin-A injection in their upper extremity and dose change in drugs for spasticity in the last 3 months.

Primary outcomes:
measure: Change from baseline hand grip strength at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline hand functions (Minnesota manuel dexterity test) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline hand functions (Purdue peg board) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline spasticity (Modified Ashworth Scale (MAS)) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline neurophysiological development (Brunnstrom stage) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline motor function (Fugl Meyer Assessment (FMA)) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline general function (Functional Independance Measure (FIM)) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline quality of life (Stroke Specific Quality of Life Scale (SS-QOL)) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline quality of life (Nottingham Extended Activities of Daily Living (NEADL)) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline cognitive state (MoCA test) at 4th week.
timeFrame: Up to 4 weeks
measure: Change from baseline emotional state (CES-depression test) at 4th week.
timeFrame: Up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Sahel Taravati
state: Bornova
Study officials:
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