The Effect of Combined Robotic Hand Therapy and Conventional Therapy in Stroke Patients

Stroke Clinical Trial

Official title:

The Effect of Combined Robotic Hand Therapy and Conventional Therapy to Rehabilitation Outcomes in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05601115
• Other study ID #: SASHR22
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: Afyonkarahisar Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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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Related Conditions & MeSH terms

• Robotic Rehabilitation
• Stroke

Intervention

Procedure:
• Robot assisted therapy
In addition to the conventional treatment for 60 minutes in the RYT group, it was planned to perform robotic rehabilitation with a hand-finger robot [Amadeo (Tyromotion, Graz, Austria)] for 30 minutes, accompanied by a physiotherapist who is trained in the field of robotic rehabilitation and has at least 5 years of experience
• Conventional Therapy Group
An exercise program consisting of 45 minutes of range of motion exercises, strengthening exercises, balance exercises and neurophysiological exercises (Brunstroom exercises) and 15 minutes of NMES was planned, accompanied by a physiotherapist experienced for at least 5 years in stroke rehabilitation, in the conventional therapy group.

Locations

Country	Name	City	State
Turkey	Sevda Adar	Afyonkarahisar

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brunnstrom stage	Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of the hemiplegic patient was defined as 6 stages. According to this staging low stage; stage 1 (flask, the stage without voluntary movement), the highest stage was determined as stage 6 (stage with isolated joint movement). Hand, upper and lower limbs in Brunnstrom staging extremities are evaluated separately.	5 minutes
Primary	upper extremity spasticity assessment	It was planned to evaluate spasticity with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0; there is no increase in muscle tone, and 4 indicates that the extremity is rigid in the direction of flexion and extension.	5 minutes
Primary	Fugl Meyer Upper Extremity Assessment Questionnaire wrist and hand assessment	The Fugl-Meyer Upper Extremity Motor Rating Scale was developed to quantitatively evaluate sensorimotor recovery after stroke.Based on Brunnstrom's stages of motor recovery	15 minutes
Primary	ABILHAND Stroke Hand Function Questionnaire	The ABILHAND Hand Questionnaire was developed in 1998 to measure patient-perceived dexterity. It contains 23 questions about how difficult the patient has to do the activities. impossible (0 points), difficult (1 point), easly (2 points) options is marked. The total score is 46.	15 minutes
Secondary	Functional Independence Scale	It is a scale that evaluates the performance of individuals regarding activities of daily living. It consists of 18 items and evaluates the functions of individuals in 2 main sections: physical/motor function (13 items) and cognitive function (5 items). The items also include 6 subheadings (self-care, sphincter control, transfers, movement, communication, and social-perception).; Each item is scored between 1-7; 1 indicates full assistance and 7 indicates complete independence. The total score ranges between 18-126 (fully dependent-fully independent).	20 minutes
Secondary	Stroke Impact Survey	- The Stroke Impact Scale (SIS) is a stroke-specific measure of health status. It consists of a total of 59 items and 8 sections. The patient is asked to evaluate the difficulty experienced in completing each item in the last week on a five-point Likert scale. One point indicates that the patient could not complete the item, and five points indicate that he had no difficulty in completing it. It also includes a visual analog scale (0: No recovery, 100: Complete recovery) related to the perception of general recovery after stroke	20 minutes
Secondary	Stroke Specific Quality of Life Scale: SSQOL	The SSQOL is a stroke-specific, patient-centered quality of life measure. The SSQOL contains 49 items and consists of 12 areas; mobility, energy, upper extremity function, work/production, mood, self care, social roles, family roles, vision, language, thinking, and personality. Each area consists of at least 3 items, and each item is evaluated on a 5-point Likert scale, taking into account the last week.Higher scores reflect better function.	30 minutes
Secondary	short form 36	This is a self-administered scale, which is widely used to measure the quality of life. It was developed to measure the quality of life in patients who have physical illnesses; however, it can also be successfully used in healthy individuals and patients who have psychiatric diseases. SF-36 includes 36 items and surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health. Total score was between 0 ( disability) and 100 (no disability). Every subgroup of the questionnaire has a score scale between 0 and 100 Every increase in the subgroup of SF-36 questionnaire, which is a positive scoring system, indicates increase in quality of life related to health.	30 minutes