StrokeNCT04353622
Exoskeleton-assisted Upper Limb Rehabilitation After Stroke
A study testing Exoskeleton robot for upper extremity and Conventional physiotherapy in people with Stroke and Upper Extremity Dysfunction, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
In recent studies, it has been observed that robotic devices make a positive contribution to motor recovery and the activities of daily living. However, studies about the effects of stroke rehabilitation with robotic devices are limited. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Stroke, Upper Extremity Dysfunction
- What is being tested?
- Exoskeleton robot for upper extremity and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having ischemic or hemorrhagic stroke history
- Being at the age between 40 and 85
- MAS (Modified Ashworth Scale) < 3 for upper extremity
- At least 6 months after stroke
- Participants who agree to participate in the study
Who cannot join
- Cardiovascular weakness (severe hypertension, coronary artery disease)
- Mini-Mental State Examination score < 24
- Recurrent stroke
- Having other orthopedic and neurologic conditions that may affect upper extremity movement
- Having behavioral and cognitive problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Health Sciences
Istanbul
About this study
Official title: Exoskeleton-assisted Upper Limb Rehabilitation After Stroke: A Randomized Controlled Trial
In recent studies, it has been observed that robotic devices make a positive contribution to motor recovery and the activities of daily living. However, studies about the effects of stroke rehabilitation with robotic devices are limited.
This study aimed to investigate the effect of upper extremity robotic rehabilitation on motor function and quality of life in stroke patients.
Read the detailed description
Stroke survivors have difficulties in participating in activities of daily living due to functional disabilities. The majority of patients after stroke need rehabilitation to gain independence in daily life as the first target. Therefore, different treatment approaches are used in stroke rehabilitation.
The use of technology in stroke rehabilitation has become very common in recent years. Robotic devices used in rehabilitation enhance the healing process by giving patients more intensive and task-oriented exercises. A lot of systematic and meta-analysis studies have shown that robot-assisted devices provide positive motor recoveries, especially in the treatment of upper extremities. However, the optimal timing, duration, and dose of robotic rehabilitation that should be applied after stroke remain uncertain.
In the light of this information, this study examines the effects of the robotic device produced for upper limb rehabilitation on daily life activities and motor function.
- Conditions
- Stroke, Upper Extremity Dysfunction
- Being tested
- Exoskeleton robot for upper extremity, Conventional physiotherapy
- Keywords
- Stroke, Upper extremity, Robotic rehabilitation, Motor function, Quality of life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exoskeleton robot for upper extremityDevice
Robot-assisted Treatment Program:
- 10 minutes elbow flexion/extension
- 10 minutes forearm supination/pronation
- 10 minutes wrist flexion/extension
- 10 minutes ulnar/radial deviation
Frequency: 2/week Duration: 12 sessions (6 weeks)
Conventional physiotherapyOther
Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted Treatment | Active comparator | Rehabilitation protocol was applied with robotic device (HOUSTONBIONİCS ExoRehab UE1). Receives: Device: Exoskeleton robot for upper extremity |
| Conventional Physiotherapy | Active comparator | Conventional physiotherapy program included neurophysiological approaches. Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Assessment
Fugl-Meyer Upper Extremity Assessment is an index to assess physical performance in individuals who had a stroke. This index consists of 33 items. Each item scored between 0 and 2. The highest score for the upper extremity is 66.
Measured: before treatment and at six weeks of the beginning of the treatment
Modified Ashworth Scale
Modified Ashworth Scale is used for measuring the spasticity of upper extremity skeletal muscle. The Modified Ashworth Scale (MAS) is scored from 0 to 5 to measure the resistance encountered when performing passive muscle stretching. The lowest score is 0 (no spasticity) and the highest score is 5 (severe spasticity).
Measured: before treatment and at six weeks of the beginning of the treatment
Secondary outcomes (2)
Upper Extremity Motor Activity Log
Upper Extremity Motor Activity Log consists of two subscales (amount of use and quality of movement) that determine how often the patient uses the affected side in daily life activities and how successful this activity is. Items on each scale are scored between 0 and 5.
Measured: before treatment and at six weeks of the beginning of the treatment
Nottingham Extended Activities of Daily Living Scale
Nottingham Extended Activities of Daily Living Scale is designed for stroke patients but can be also used for other diseases. The scale has 22 items divided into 4 areas of daily life. These areas are mobility, kitchen, domestic and leisure activities. Each item scored between 0 and 3. The highest score of scale is 66.
Measured: before treatment and at six weeks of the beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Feb 2019
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, iremakgun, Marmara University
- Investigators
- İrem Akgün, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353622
- Sponsor's protocol ID
- 09.2019.146
- Status last verified
- Oct 2023
- First submitted
- 21 Feb 2020
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exoskeleton-assisted Upper Limb Rehabilitation After Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04353622
- Acronym / sponsor ID
- 09.2019.146
- Conditions
- Stroke, Upper Extremity Dysfunction
- Keywords
- Stroke, Upper extremity, Robotic rehabilitation, Motor function, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In recent studies, it has been observed that robotic devices make a positive contribution to motor recovery and the activities of daily living. However, studies about the effects of stroke rehabilitation with robotic devices are limited.
This study aimed to investigate the effect of upper extremity robotic rehabilitation on motor function and quality of life in stroke patients.
Detailed description
Stroke survivors have difficulties in participating in activities of daily living due to functional disabilities. The majority of patients after stroke need rehabilitation to gain independence in daily life as the first target. Therefore, different treatment approaches are used in stroke rehabilitation.
The use of technology in stroke rehabilitation has become very common in recent years. Robotic devices used in rehabilitation enhance the healing process by giving patients more intensive and task-oriented exercises. A lot of systematic and meta-analysis studies have shown that robot-assisted devices provide positive motor recoveries, especially in the treatment of upper extremities. However, the optimal timing, duration, and dose of robotic rehabilitation that should be applied after stroke remain uncertain.
In the light of this information, this study examines the effects of the robotic device produced for upper limb rehabilitation on daily life activities and motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted Treatment | Active comparator | Device: Exoskeleton robot for upper extremityRehabilitation protocol was applied with robotic device (HOUSTONBIONİCS ExoRehab UE1). |
| Conventional Physiotherapy | Active comparator | Other: Conventional physiotherapyConventional physiotherapy program included neurophysiological approaches. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having ischemic or hemorrhagic stroke history
- Being at the age between 40 and 85
- MAS (Modified Ashworth Scale) < 3 for upper extremity
- At least 6 months after stroke
- Participants who agree to participate in the study
Key exclusion criteria (5 listed)
- Cardiovascular weakness (severe hypertension, coronary artery disease)
- Mini-Mental State Examination score < 24
- Recurrent stroke
- Having other orthopedic and neurologic conditions that may affect upper extremity movement
- Having behavioral and cognitive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exoskeleton robot for upper extremityRobot-assisted Treatment Program: * 10 minutes elbow flexion/extension * 10 minutes forearm supination/pronation * 10 minutes wrist flexion/extension * 10 minutes ulnar/radial deviation Frequency: 2/week Duration: 12 sessions (6 weeks) | Device | Robot-assisted Treatment |
| Conventional physiotherapyFerquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes | Other | Conventional Physiotherapy |
Primary outcome
Fugl-Meyer Upper Extremity Assessment
Time frame: before treatment and at six weeks of the beginning of the treatment
Fugl-Meyer Upper Extremity Assessment is an index to assess physical performance in individuals who had a stroke. This index consists of 33 items. Each item scored between 0 and 2. The highest score for the upper extremity is 66.
Modified Ashworth Scale
Time frame: before treatment and at six weeks of the beginning of the treatment
Modified Ashworth Scale is used for measuring the spasticity of upper extremity skeletal muscle. The Modified Ashworth Scale (MAS) is scored from 0 to 5 to measure the resistance encountered when performing passive muscle stretching. The lowest score is 0 (no spasticity) and the highest score is 5 (severe spasticity).
2 secondary outcomes
Upper Extremity Motor Activity Log
Time frame: before treatment and at six weeks of the beginning of the treatment
Nottingham Extended Activities of Daily Living Scale
Time frame: before treatment and at six weeks of the beginning of the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İrem Akgün principal investigator
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton robot for upper extremity and Conventional physiotherapy in people with Stroke and Upper Extremity Dysfunction, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Assessment (time frame: before treatment and at six weeks of the beginning of the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.