Robot-Assisted Therapy in Chronic Stroke Patients

November 15, 2024 updated by: Sevda Adar, Afyonkarahisar Health Sciences University

Investigation of the Effects of Robot-Assisted Therapy Added to Conventional Therapy on Hand Functions, Spasticity and Quality of Life in Patients With Chronic Stroke: A Randomized Controlled 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is one of the leading causes of disability worldwide. Although mortality is decreasing, the number of people living with the effects of stroke has increased due to the increasing and aging population. It has been observed that 26% of patients have decreased basic daily living activities and 50% have decreased mobility after stroke.

Effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises performed with high intensity and duration. In this context, in addition to traditional treatments, many new treatment approaches have come to the fore in recent years. Robot-assisted treatment (RAT) is one of these new treatment approaches. The use of robotic technology in rehabilitation has gained importance especially in the last 15 years and developments in this regard continue to increase. RAT is an innovative approach that includes intensive, repeatable, interactive and personalized applications.

This technology-based treatment increases the efficiency of rehabilitation care with its features of intensity, interaction, flexibility and adaptability to the patient performance and needs. It has no significant side effects and is well tolerated by patients. In the literature on robot-assisted treatment, different robotic devices have been used in various studies and different treatment protocols have been applied. This treatment has been reported to provide significantly greater improvement in function compared to conventional usual care. Studies in the literature on RAT demonstrate the feasibility of using these technologies in large patient groups.

The most common and devastating consequence of post-stroke disability is functional disability in the upper extremity. The functional prognosis of the lower extremity is generally better than the upper extremity after stroke. 20-30% of patients can walk normally, and 75% can reach some stage of ambulation. However, only 5% of patients return to normal upper extremity function, while 23-43% show inadequate functional recovery. Therefore, upper extremity rehabilitation requires more time and effort than lower extremity rehabilitation.

Bertani et al. In their published meta-analysis, they stated that robot-assisted rehabilitation is more effective in improving upper extremity motor function, especially in patients with chronic stroke, compared to conventional therapy. Amadeo (Tyromotion, Graz, Austria), an end-effector robotic rehabilitation device designed for hand rehabilitation, has shown feasibility and preliminary efficacy for stroke in the subacute phase. A randomized controlled trial with 17 patients compared conventional occupational therapy with Amadeo robotic therapy and after forty sessions, both groups showed significant improvement, but robotic intervention caused a greater improvement in hand function as measured by Fugl-Meyer and Motricity Index. Robotic hand therapy has started to take its place in routine rehabilitation protocols today. Considering the scarcity of studies on robotic hand therapy, it has been seen that 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • botulinum toxin injection into the upper extremity within the last 6 months
  • skin ulcers
  • brainstem or cerebellar lesions
  • neglect or apraxia
  • severe visual defects
  • severe depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Conventional Therapy
It 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.
Procedure: conventional rehabilitation
It 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.
Experimental: Robot Assisted Therapy
In 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.
Procedure: conventional rehabilitation
It 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.
Procedure: robotic rehabilitation
In 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Brunnstrom Staging
Time Frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
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.
Before treatment (T0) At the end of the treatment (10. week) (T1)
Modified Ashworth Scale
Time Frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
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.
Before treatment (T0) At the end of the treatment (10. week) (T1)
Fugl Meyer Upper Extremity Assessment Questionnaire
Time Frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
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.
Before treatment (T0) At the end of the treatment (10. week) (T1)
ABILHAND Stroke Hand Function Questionnaire
Time Frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
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.
Before treatment (T0) At the end of the treatment (10. week) (T1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mini Mental Test
Time Frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
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.
Before treatment (T0) At the end of the treatment (10. week) (T1)
Stroke Impact Survey
Time Frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
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.
Before treatment (T0) At the end of the treatment (10. week) (T1)
Stroke Specific Quality of Life Scale (SSQOL)
Time Frame: Before treatment (T0) At the end of the treatment (10. week) (T1)
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.
Before treatment (T0) At the end of the treatment (10. week) (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Afyonkarahisar Health Sciences University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAROBOT2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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