Upper Extremity Robotic Rehabilitation in Patients With Hemiplegia

NCT ID: NCT04393480

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-14
• Study Completion Date: 2019-04-14

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.

Conditions

Hemiplegia and/or Hemiparesis Following Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Robotic therapy

Robotic rehabilitation and conventional rehabilitation

Group Type: ACTIVE_COMPARATOR

Robotic therapy

Intervention Type: OTHER

ReoGo™ - Motorika robotic therapy - upper extremity robotic rehabilitation system

Conventional therapy

Intervention Type: OTHER

Range of Motion (ROM) exercises, muscle strengthening, balance and mobility training, exercises for enhancing activities of daily life, neurophysiological exercises, turnings, bed movements, bridge building, sitting and transfer training, gait training, proprioceptive exercises, balance exercises on the balance board of those affected by the cerebellar system, occupational therapy, cognitive rehabilitation by the relevant psychologist given to those with cognitive impairment

Conventional therapy

Conventional rehabilitation

Group Type: SHAM_COMPARATOR

Conventional therapy

Intervention Type: OTHER

Range of Motion (ROM) exercises, muscle strengthening, balance and mobility training, exercises for enhancing activities of daily life, neurophysiological exercises, turnings, bed movements, bridge building, sitting and transfer training, gait training, proprioceptive exercises, balance exercises on the balance board of those affected by the cerebellar system, occupational therapy, cognitive rehabilitation by the relevant psychologist given to those with cognitive impairment

Interventions

Robotic therapy

ReoGo™ - Motorika robotic therapy - upper extremity robotic rehabilitation system

Intervention Type: OTHER

Conventional therapy

Range of Motion (ROM) exercises, muscle strengthening, balance and mobility training, exercises for enhancing activities of daily life, neurophysiological exercises, turnings, bed movements, bridge building, sitting and transfer training, gait training, proprioceptive exercises, balance exercises on the balance board of those affected by the cerebellar system, occupational therapy, cognitive rehabilitation by the relevant psychologist given to those with cognitive impairment

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahel Taravati, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Sahel Taravati, M.D.

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sahel Taravati

Izmir, Bornova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

STKC2019

Identifier Type: -

Identifier Source: org_study_id