StrokeNCT06184191
Combined Robotic Hand Rehabilitation and Conventional Rehabilitation for Post-stroke Rehabilitation
A study testing Robotic hand rehabilitation in people with Stroke and Hemiplegia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: The investigators compared the effectiveness of individual and combined application of conventional rehabilitation and robotic hand rehabilitation in post-stroke hemiplegia. The study design is an An assessor-blinded, prospective randomized comparison study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Robotic hand rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cortical or subcortical stroke confirmed by radiological imaging
- Over 18 years old age
- Mini-Mental Scale (MMS) = 24-30
- Not having serious cognitive impairment (score ≥22)
- The rehabilitation of the patient was performed at the rehabilitation department of XXXXX Research and Training Hospital.
Who cannot join
- Having a stroke lesion in other areas of the brain such as the cerebellum and brainstem
- Presence of joint or bone pathologies in the affected upper extremity
- Excessive spasticity in the elbow or wrist joints of the affected upper extremity (Modified Ashworth Scale score >3)
- Having previously surgical treatment history on the affected extremity
- Having an additional neurological disease
- Not complying with treatment recommendations or inadequately applying.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital
Istanbul, Gaziosmanpaşa, 34255
About this study
Official title: Comparison of the Effects of Combined and Individual Robotic Hand Rehabilitation and Conventional Rehabilitation on Daily Living Activity, Upper Extremity Functional Results and Hand Strength in Patients With Post-stroke Hemiplegia
Objective: The investigators compared the effectiveness of individual and combined application of conventional rehabilitation and robotic hand rehabilitation in post-stroke hemiplegia. The study design is an An assessor-blinded, prospective randomized comparison study.
Methods: Patients were randomly assigned to one of three groups:
Read more
Group 1 (Robotic Hand Rehabilitation): The patients underwent robotic hand rehabilitation, Group 2 (Conventional Rehabilitation): The patients underwent conventional rehabilitation, Group 3 (Combined Rehabilitation): The patients underwent combined conventional and robotic hand rehabilitation at the same period.
Randomization was performed using the closed envelope method randomization sequence by an investigator who was not involved in patient care. The therapist opened the envelope 6 hours before the patient started treatment.
The investigators assessed Barthel index for activities of daily living (range, 0 - 100), Brunnstrom's hemiplegia recovery staging (range, stage 1 - stage 7), Fugl-Meyer upper extremity assessment scale (stage, 0 - 66), Abilhand stroke hand ability questionnaire assessment (range, 0 - 46), hand grip strength, and hand pinch strength at baseline and end of the rehabilitation (1-month).
Conclusions: There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke. They revealed that both therapies had a positive effect on the results. There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions. More successful hand functional results may be achieved by applying both rehabilitations together in stroke. The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke. Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity.
Read the detailed description
Objective: Hemiplegia or hemiparesis is commonly seen after stroke.Upper limb function, particularly hand function, plays a crucial role in determining the quality of life and independence after stroke. Numerous studies have been conducted on rehabilitation to improve upper extremity function.There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke. They revealed that both therapies had a positive effect on the results. There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions. More successful hand functional results may be achieved by applying both rehabilitations together in stroke. The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke. Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity.
Methods: 66 patients with post-stroke hemiplegia will include in our study. Grip strength was measured with a dynamometer (JamarR, PrestonTM, Jackson, MI) and pinch strength was measured with a specially designed instrument (Pinch gauge, B\&R EngineeringTM, Santa Fe Springs, CA). Measurements were made 3 times and the average value was taken. The patients were evaluated before rehabilitation and at the first month follow-up. The same therapist who was blind to the type of rehabilitation evaluated the patients before treatment and at the first month follow-up.
Conclusions: Combined Rehabilitation achieves results just as successful as Conventional Rehabilitation in terms of daily living activities, upper extremity functions, and hand functions. Additionally, it significantly outperformed Conventional Rehabilitation in improving hand functions, treating hand spasticity, and enhancing hand strength.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Robotic hand rehabilitation
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic hand rehabilitationOther
Also called Conventional rehabilitation, Combined conventional and robotic hand rehabilitation
Robotic hand rehabilitation devices are the most advanced, effective and user-friendly combination of technology to support motor rehabilitation of the upper limb and neurocognitive recovery. Serving patients, doctors, therapists through therapies and protocols that accompany all stages of the rehabilitation process, the devices promote the functional recovery of patients and their reintegration into daily life.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Hand Rehabilitation | Active comparator | RHR group received hand rehabilitation through the robotic device. A home-based rehabilitation program was used to these patients for hand and upper extremity rehabilitation in addition to RHR.
Each rehabilitation session consisted of six parts:
1. A sequence of 17 cycles of digital flexion-extension joint motions, from the thumb to the fifth finger (7 min).
2. A sequence of 23 cycles of motion to counting from one to five (7 min).
3. A sequence of 70 cycles of motions including thumb-finger opposition motions from the second to the fifth finger (7 min).
4. A sequence of 28 cycles of motions including wave-like finger motions (7 min).
5. A sequence of 42 cycles of motions including fist opening/closing (7 min).
6. A sequence of 20 cycles of motions including flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
The patients underwent Robotic Hand Rehabilitation in the hospital 5 days per week for 1 month. Receives: Other: Robotic hand rehabilitation |
| Conventional Rehabilitation | Active comparator | CVR group received 60 minutes of consecutive occupational therapy sessions in the hospital 5 days per week for 1 month. The rehabilitation program involved strength, balance, manual dexterity exercises, and stretching/weight-bearing by the affected arm. Treatments focused on practice of specific functional tasks when possible. These included reach and grasp of various objects, isolated hand motions (writing, playing an instruments, molding putty, cooking), and whole body activities (swinging a racquet, basketball handling skills). The rehabilitation also included training in ADLs. The patients underwent individualized programs based on assessment and patient goals. Manual therapy techniques were used to obtain isometric contractions in weak muscles. The patients received mobilization and stretching exercises to restricted joints as needed to increase range of motion. Receives: Other: Robotic hand rehabilitation |
| Combined Rehabilitation | Experimental | The patients underwent 60 minutes of CVR followed by 40 minutes of hand rehabilitation through the robotic device. A home-based rehabilitation was not involve in this group. Receives: Other: Robotic hand rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index for activities of daily living
Barthel index was used to evaluate the daily living activities of the patients. Total score is between 0 - 100. 0 - 20 completely dependent, 21 - 61 highly dependent, 62 - 90 moderately dependent, 91 - 99 slightly dependent, 100 completely independent.
Measured: The patients were evaluated before rehabilitation and at the first month follow-up.
Brunnstrom's hemiplegia recovery staging
It was used to evaluate hemiplegia recovery upper extremity. It has 7 stages. Stage 1: There is no movement in the held arm. It is flask. Stage 7: Normal motor function is regained.
Measured: The patients were evaluated before rehabilitation and at the first month follow-up.
Fugl-Meyer upper extremity assessment scale
It was used to evaluate upper extremity function. Total score is between 0 - 66.
Measured: The patients were evaluated before rehabilitation and at the first month follow-up.
ABILHAND stroke hand ability questionnaire assessment
It was used to evaluate stroke hand function. Total score is between 0 - 46.
Measured: The patients were evaluated before rehabilitation and at the first month follow-up.
grip strength, and pinch strength
It was used to evaluate hand strength.
Measured: The patients were evaluated before rehabilitation and at the first month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Nov 2022
- Primary completion1 May 2023
- Study completion1 Nov 2023
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Betül Başar, Gaziosmanpasa Research and Education Hospital
- Investigators
- BETÜL BAŞAR, Ass. Prof., Study chair, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184191
- Sponsor's protocol ID
- GaziosmanpaşaTraining&Research
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be shared upon request from the responsible author.
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Combined and Individual Robotic Hand Rehabilitation and Conventional Rehabilitation on Daily Living Activity, Upper Extremity Functional Results and Hand Strength in Patients With Post-stroke Hemiplegia
- ClinicalTrials.gov ID
- NCT06184191
- Acronym / sponsor ID
- GaziosmanpaşaTraining&Research
- Conditions
- Stroke, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 28 Dec 2023 (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.
Objective: The investigators compared the effectiveness of individual and combined application of conventional rehabilitation and robotic hand rehabilitation in post-stroke hemiplegia. The study design is an An assessor-blinded, prospective randomized comparison study.
Methods: Patients were randomly assigned to one of three groups:
Group 1 (Robotic Hand Rehabilitation): The patients underwent robotic hand rehabilitation, Group 2 (Conventional Rehabilitation): The patients underwent conventional rehabilitation, Group 3 (Combined Rehabilitation): The patients underwent combined conventional and robotic hand rehabilitation at the same period.
Randomization was performed using the closed envelope method randomization sequence by an investigator who was not involved in patient care. The therapist opened the envelope 6 hours before the patient started treatment.
The investigators assessed Barthel index for activities of daily living (range, 0 - 100), Brunnstrom's hemiplegia recovery staging (range, stage 1 - stage 7), Fugl-Meyer upper extremity assessment scale (stage, 0 - 66), Abilhand stroke hand ability questionnaire assessment (range, 0 - 46), hand grip strength, and hand pinch strength at baseline and end of the rehabilitation (1-month).
Conclusions: There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke. They revealed that both therapies had a positive effect on the results. There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions. More successful hand functional results may be achieved by applying both rehabilitations together in stroke. The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke. Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity.
Detailed description
Objective: Hemiplegia or hemiparesis is commonly seen after stroke.Upper limb function, particularly hand function, plays a crucial role in determining the quality of life and independence after stroke. Numerous studies have been conducted on rehabilitation to improve upper extremity function.There are many studies in the literature on the hand and upper extremity functions of Conventional Rehabilitation and Robotic Hand Rehabilitation in stroke. They revealed that both therapies had a positive effect on the results. There is no study on the effect of combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions. More successful hand functional results may be achieved by applying both rehabilitations together in stroke. The aim of our study is to compare the effects of early-term individually and concomitant Conventional Rehabilitation and Robotic Hand Rehabilitation on hand and upper extremity functions and hand strength in stroke. Our hypothesis is that the combined application of Conventional Rehabilitation and Robotic Hand Rehabilitation together will provide better functional results of the hand and upper extremity.
Methods: 66 patients with post-stroke hemiplegia will include in our study. Grip strength was measured with a dynamometer (JamarR, PrestonTM, Jackson, MI) and pinch strength was measured with a specially designed instrument (Pinch gauge, B\&R EngineeringTM, Santa Fe Springs, CA). Measurements were made 3 times and the average value was taken. The patients were evaluated before rehabilitation and at the first month follow-up. The same therapist who was blind to the type of rehabilitation evaluated the patients before treatment and at the first month follow-up.
Conclusions: Combined Rehabilitation achieves results just as successful as Conventional Rehabilitation in terms of daily living activities, upper extremity functions, and hand functions. Additionally, it significantly outperformed Conventional Rehabilitation in improving hand functions, treating hand spasticity, and enhancing hand strength.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Robotic Hand Rehabilitation | Active comparator | Other: Robotic hand rehabilitationRHR group received hand rehabilitation through the robotic device. A home-based rehabilitation program was used to these patients for hand and upper extremity rehabilitation in addition to RHR. Each rehabilitation session consisted of six parts: 1. A sequence of 17 cycles of digital flexion-extension joint motions, from the thumb to the fifth finger (7 min). 2. A sequence of 23 cycles of motion to counting from one to five (7 min). 3. A sequence of 70 cycles of motions including thumb-finger opposition motions from the second to the fifth finger (7 min). 4. A sequence of 28 cycles of motions including wave-like finger motions (7 min). 5. A sequence of 42 cycles of motions including fist opening/closing (7 min). 6. A sequence of 20 cycles of motions including flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min). The patients underwent Robotic Hand Rehabilitation in the hospital 5 days per week for 1 month. |
| Conventional Rehabilitation | Active comparator | Other: Robotic hand rehabilitationCVR group received 60 minutes of consecutive occupational therapy sessions in the hospital 5 days per week for 1 month. The rehabilitation program involved strength, balance, manual dexterity exercises, and stretching/weight-bearing by the affected arm. Treatments focused on practice of specific functional tasks when possible. These included reach and grasp of various objects, isolated hand motions (writing, playing an instruments, molding putty, cooking), and whole body activities (swinging a racquet, basketball handling skills). The rehabilitation also included training in ADLs. The patients underwent individualized programs based on assessment and patient goals. Manual therapy techniques were used to obtain isometric contractions in weak muscles. The patients received mobilization and stretching exercises to restricted joints as needed to increase range of motion. |
| Combined Rehabilitation | Experimental | Other: Robotic hand rehabilitationThe patients underwent 60 minutes of CVR followed by 40 minutes of hand rehabilitation through the robotic device. A home-based rehabilitation was not involve in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with cortical or subcortical stroke confirmed by radiological imaging
- Over 18 years old age
- Mini-Mental Scale (MMS) = 24-30
- Not having serious cognitive impairment (score ≥22)
- The rehabilitation of the patient was performed at the rehabilitation department of XXXXX Research and Training Hospital.
Key exclusion criteria (6 listed)
- Having a stroke lesion in other areas of the brain such as the cerebellum and brainstem
- Presence of joint or bone pathologies in the affected upper extremity
- Excessive spasticity in the elbow or wrist joints of the affected upper extremity (Modified Ashworth Scale score >3)
- Having previously surgical treatment history on the affected extremity
- Having an additional neurological disease
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 |
|---|---|---|
| Robotic hand rehabilitationAlso: Conventional rehabilitation, Combined conventional and robotic hand rehabilitationRobotic hand rehabilitation devices are the most advanced, effective and user-friendly combination of technology to support motor rehabilitation of the upper limb and neurocognitive recovery. Serving patients, doctors, therapists through therapies and protocols that accompany all stages of the rehabilitation process, the devices promote the functional recovery of patients and their reintegration into daily life. | Other | Combined Rehabilitation, Conventional Rehabilitation, Robotic Hand Rehabilitation |
Primary outcome
Barthel index for activities of daily living
Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.
Barthel index was used to evaluate the daily living activities of the patients. Total score is between 0 - 100. 0 - 20 completely dependent, 21 - 61 highly dependent, 62 - 90 moderately dependent, 91 - 99 slightly dependent, 100 completely independent.
Brunnstrom's hemiplegia recovery staging
Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.
It was used to evaluate hemiplegia recovery upper extremity. It has 7 stages. Stage 1: There is no movement in the held arm. It is flask. Stage 7: Normal motor function is regained.
Fugl-Meyer upper extremity assessment scale
Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.
It was used to evaluate upper extremity function. Total score is between 0 - 66.
ABILHAND stroke hand ability questionnaire assessment
Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.
It was used to evaluate stroke hand function. Total score is between 0 - 46.
grip strength, and pinch strength
Time frame: The patients were evaluated before rehabilitation and at the first month follow-up.
It was used to evaluate hand strength.
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 28 Dec 2023.
- Individual participant dataSharing planned: No. Individual participant data will be shared upon request from the responsible author.
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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.
BETÜL BAŞAR, Ass. Prof. study chair
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic hand rehabilitation in people with Stroke and Hemiplegia, run by Gaziosmanpasa Research and Education Hospital 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 6 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 28 Dec 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?
Barthel index for activities of daily living (time frame: The patients were evaluated before rehabilitation and at the first month follow-up.). The study lists 5 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 28 Dec 2023.