Clinical trial NCT05601115: The Effect of Combined Robotic Hand Therapy and Conventional Therapy in Stroke Patients
Official title: The Effect of Combined Robotic Hand Therapy and Conventional Therapy to Rehabilitation Outcomes in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Robot Assisted Therapy
Robotic Rehabilitation
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.The aim of tihis study is to investigate the effect of robotic hand therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients.

Detailed description: Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come up in recent years. Robot-assisted therapy (RAT) is one of these new treatment approaches. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications. It is seen that robotic systems are very suitable for the patient to receive more intense and task-oriented motor training by integrating with other rehabilitation approaches. Considering the scarcity of studies on robotic hand therapy, it was seen that larger scale and long-term studies are needed. In this study, investigators aimed to investigate the effect of robotic hand therapy added to conventional rehabilitation on motor functions and quality of life in stroke patients. Patients will be evaluated pretreatment, posttreatment and 3 months later after treatment. Evaluation parameters consist of Brunnstrom Staging, Modified Ashworth Scale (MAS), Fugl Meyer Assessment of The Upper Extremity, Functional Independence Measure Scale (FIM) and ABILHAND Questionnaire, Stroke Impact Scale (SIS), Stroke-Specific Quality of Life Scale (SS-QOL) and SF-36 Quality of Life Questionnaire. We think that robot-assisted therapy will contribute to the improvement of hand functions and quality of life in stroke patients.

Eligibility criteria: Inclusion Criteria:

Unilateral stroke

Between 4 weeks and 6 months after stroke

health status was suitable for rehabilitation

who could understand commands with a mini mental test score of 15 and above

who had Brunnstrom grade 3 and below (≤3).

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Exclusion Criteria:

Patients with persistent upper extremity pain on the hemiplegic side (VAS\>40)

Patients with severe spasticity in the hand (MAS≥3)

Patients with contractures in the hand

Patients who had fractures or operations on the hemiplegic side in the last 6 months

Patients who received botulinum toxin injection to the upper extremity in the last 6 months

Patients with skin ulcers

Patients with brain stem or cerebellar lesions

Patients with neglect or apraxia

Patients with severe visual impairment and severe depression

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Primary outcomes:
measure: Brunnstrom stage
timeFrame: 5 minutes
measure: upper extremity spasticity assessment
timeFrame: 5 minutes
measure: Fugl Meyer Upper Extremity Assessment Questionnaire wrist and hand assessment
timeFrame: 15 minutes
measure: ABILHAND Stroke Hand Function Questionnaire
timeFrame: 15 minutes
Secondary outcomes:
measure: Functional Independence Scale
timeFrame: 20 minutes
measure: Stroke Impact Survey
timeFrame: 20 minutes
measure: Stroke Specific Quality of Life Scale: SSQOL
timeFrame: 30 minutes
measure: short form 36
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Sevda Adar
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: SEVDA ADAR
role: PRINCIPAL_INVESTIGATOR
References: