Robot-Assisted Therapy in Chronic Stroke Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorAfyonkarahisar Health Sciences University
About this trial
Considering the paucity of studies on robotic hand therapy, larger-scale and long-term follow-up studies are needed. The aim in this study is to demonstrate the effectiveness of robot-assisted hand therapy in patients with chronic stroke and to compare this effectiveness in patients with different Brunnstrom stages.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
who were 3 months post-CVA
whose health status was suitable for rehabilitation
who could understand commands with a mini mental test score of 15 and above.
Disqualifiers
Patients with persistent upper extremity pain on the hemiplegic side (VAS>40)
severe spasticity in the hand (MAS≥3)
contracture in the hand
fracture or surgery on the hemiplegic side within the last 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
robotic rehabilitation
Procedure/SurgeryIn addition to conventional therapy, the robotic therapy group was planned to receive robotic rehabilitation with a hand-finger robot \[Amadeo (Tyromotion, Graz, Austria)\] for 45 minutes, accompanied by a physiotherapist trained in robotic rehabilitation and with at least 5 years of experience. A total of 20 treatment sessions will be applied 2 days a week.
conventional rehabilitation
Procedure/SurgeryIt was planned for the conventional therapy group to receive an exercise program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. A total of 20 treatment sessions will be applied 2 days a week.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Conventional TherapyActive comparator 1 intervention
Group B: Robot Assisted TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Brunnstrom Staging
is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In the Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.
Time frame
Before treatment (T0) At the end of the treatment (10. week) (T1)2
Modified Ashworth Scale
Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.
Time frame
Before treatment (T0) At the end of the treatment (10. week) (T1)3
Fugl Meyer Upper Extremity Assessment Questionnaire
The Fugl-Meyer Upper Extremity Motor Assessment Scale (FMUE Scale) was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom\'s stages of motor recovery. The FMUE Scale consists of 33 items, each scored from 0 to 2, where 0 = cannot perform, 1 = partially performs, and 2 = fully performs. The total score is 66.
Time frame
Before treatment (T0) At the end of the treatment (10. week) (T1)4
ABILHAND Stroke Hand Function Questionnaire
ABILHAND Hand Questionnaire was developed in 1998 to measure the hand skill perceived by the patient. It contains 23 questions about how much difficulty the patient has in performing the activities. One of the options impossible (0 points), difficult (1 point), easy (2 points) is marked. The total score is 46.
Time frame
Before treatment (T0) At the end of the treatment (10. week) (T1)Secondary outcomes
1
Mini Mental Test
The Mini Mental State Examination is a widely used cognitive screening test. The total score is 30 points. It has been stated that scores below 15 indicate low cognitive function, scores between 15-26 indicate moderate, and scores above 26 indicate high cognitive level. Turkish validity studies have been conducted in the normal population and in patients with traumatic brain injury.
Time frame
Before treatment (T0) At the end of the treatment (10. week) (T1)2
Stroke Impact Survey
The Stroke Impact Scale (SIS) is a stroke-specific health status measure. It consists of 59 items and 8 sections. The patient is asked to rate the difficulty experienced in completing each item in the past week on a five-point Likert scale. A score of one indicates that the patient was unable to complete the item, and a score of five indicates that the patient had no difficulty in completing it. It also includes a visual analog scale (0: No improvement, 100: Full improvement) regarding the perception of general recovery after stroke. Validity and reliability studies have been conducted in Turkish.
Time frame
Before treatment (T0) At the end of the treatment (10. week) (T1)3
Stroke Specific Quality of Life Scale (SSQOL)
SSQOL is a stroke-specific, patient-centered quality of life measure. SSQOL contains 49 items and consists of 12 domains; mobility, energy, upper extremity function, work/production, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Each domain consists of at least 3 items, and each item is evaluated on a 5-point Likert scale considering the past week. Higher scores reflect better function. It has been shown to be valid and reliable for the Turkish population.
Time frame
Before treatment (T0) At the end of the treatment (10. week) (T1)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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