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StrokeNCT06155058

Robotic Versus Conventional Therapy For Post-Stroke Hand Motoric Recovery

A study testing SYREBO and Conventional Mirror Method in people with Stroke and Physical Disability, run by Hasanuddin University at 3 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This clinical trial aims to compare the effectiveness of Robotic versus conventional mirror therapy among post-stroke patients. The main questions it aims to answer are: Effectiveness of both interventions in hand motoric recovery across time Effectiveness of both interventions in functional outcomes across time… Read more about this study

Who is it for?
Ages 20 to 85 years
What is being tested?
SYREBO and Conventional Mirror Method
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesIndonesia
Study dates
1 Dec 2023to 30 Mar 2024
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 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 20 - 85 years.
  • Non-haemorrhagic stroke/infarction with onset more than 3 months from the onset of the attack.
  • Patients with unilateral upper limb hemiparesis.
  • Modified Ashworth Scale (MAS) on fingers and hands <3
  • The patient has not undergone mirror therapy treatment before.
  • Patients who are able to understand informed consent to participate in research.
  • The patient had a Radiology imaging of the head at the time of stroke onset.

Who cannot join

  • Patients with severe spasticity or contractures of the upper extremities.
  • Patients with infarction/bleeding with extensive lesions covering 2 hemispheres.
  • The patient has severe cognitive impairment that will interfere with the research objectives (MMSE score >24).
  • Patients post Digital Subtraction Angiography (DSA) procedures in the last 2 months.
  • Patients with a history of seizures or epilepsy.
  • Patients with visual field deficits or severe visual impairment.
Show all 15Show fewer
  • Patients who are unable to sit upright without assistance.
  • Other uncontrolled medical conditions (musculoskeletal, neuromuscular, cardiorespiratory) that may interfere with the ability to exercise.
  • Dropout criteria:
  • Patients were excluded from the study if:
  • Participant dies.
  • Participants take part in the exercise <3 times for 2 consecutive weeks.
  • The participant refuses to continue the training session.
  • Participants experience hemodynamic disorders during the training program phase.
  • Participants experience neurological disorders during the training program phase.

Trial locations and contacts

3 sites in 1 country.

Steven Kurniawan, MD contact

+6281319912162

stvn.aupp@gmail.com

Indonesia3 sites

  • Cerebellum Clinic

    Makassar, South Sulawesi, 90231

    Yose Waluyo, MD.PhD, +62 411 427184, pelayanancerebellumclinic@gmail.com

    Yose Waluyo

  • Hasanuddin University, Faculty of Medicine

    Makassar, South Sulawesi, 90245

    Bumi Herman, MD, +62411591331, bumiherman@med.unhas.ac.id

    Steven Kurniawan, MD

  • Wahidin Sudirohusodo General Hospital

    Makassar, South Sulawesi, 90245

    Bumi Herman, Ph.D., +62 411 583333, bumiherman@med.unhas.ac.id

    Steven Kurniawan, MD

Other trials in Indonesia

About this study

Official title: Comparison Of Robotic And Conventional Mirror Therapy On Hand Motoric Recovery And Functional Outcomes For Rehabilitation Of Post-Stroke Patients

This clinical trial aims to compare the effectiveness of Robotic versus conventional mirror therapy among post-stroke patients. The main questions it aims to answer are:

  • Effectiveness of both interventions in hand motoric recovery across time
  • Effectiveness of both interventions in functional outcomes across time
  • Clinical outcome difference between both interventions Participants will be allocated into either a robotic group as the main intervention or a mirror therapy group as the active comparator. A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome
Read the detailed description
  1. Research design This research is an experimental study with a randomized controlled trial research design.
  2. Study Setting The research will be carried out among post-stroke patients at two teaching hospitals and one physical rehabilitation centre in Makassar
  3. Procedure
  4. Robotic Procedure an exoskeletal robot (Syrebo) will help and stimulate the movement of the paralyzed extremity. One set of training covering Activity Daily Living (ADL) set will be conducted. A mirror will reflect the movement of the healthy extremities
  5. Conventional Method the difference from the robotic procedure was, the movement and stimulation will be provided by the physical therapist.
  6. Time frame the procedure will be conducted in parallel three times per week for a total of six weeks
  7. Outcomes
  8. motoric ability of upper extremity using Fugl-Meyer Assessment for Upper Extremities (FMA-UE)
  9. Dexterity, coordination and response of finger using the Nine Hole Peg Test (NHPT)
  10. Covariates and potential confounders
  11. type of stroke determined by radiology imaging
  12. phase of stroke (acute, sub-acute or chronic)
  13. cognitive ability measured using mini-mental state examination (MMSE)
  14. Spasticity measured by the Modified Ashworth Scale (MAS)
  15. Procedure The data collected is primary data obtained in accordance with the inclusion criteria. Samples who are willing to become research subjects will undergo interviews, physical examinations, FMA-UE-Hand Motor Domain and NHPT examinations. The interview questionnaire in this study will contain a list of patient identities including name, age, marital status, address, educational history, employment history, history of stroke, cognitive examination (MMSE), and self-reported visual ability. The FMA-UE-Hand Motor Domain scoring system is used to evaluate upper extremity motor function in patients with neurological disorders, such as stroke. The scoring system ranges from 0-14, with higher scores indicating better motor function. The FMA-UE-Hand Motor domain assessment system is broken down into several subscales, namely Mass Flexion and Extension movements, followed by functional movements of grasping (Grasp), including Hook Grasp, Thumb Adduction, Pincer Grasp, Cylinder Grasp, and Spherical Grasp. The assessment will get a score of 0 = None or no movement, 1 = Partial or limited movement, and 2 = Full or perfect movement. The NHPT assessment consists of a square board with 9 pegs. At one end of the board, there is a hole for the peg, and at the other end, there is a shallow round plate for holding the peg. NHPT is performed by having the patient take pegs from a container, one at a time, and place them into the holes in a board, as quickly as possible. The patient must then remove the pegs from the holes, one at a time, and reinsert them into the housing. To practice and register initial scores, the test must be started with the unaffected upper limb. The board should be placed in the centre of the patient's body with the housing holding the pegs oriented toward the hand being tested. Only the hand being evaluated should perform the test. The non-evaluated hand is allowed to grip the edge of the board to provide stability. Patients are scored based on the time required to complete the test activity, recorded in seconds. The stopwatch must start from the moment the participant touches the first peg until the last peg touches the container. This assessment requires a board, of wood or plastic, with 9 holes (10 mm diameter, 15 mm depth), spaced 32 mm or 50 mm apart and a stopwatch.
  16. Sample Size Based on previous research, the value of the standard deviation of the selected outcome = 11.5 and the value of x1-x2 = 9.1 (Lin, 2020). The Zα value = 1.96 with a confidence interval of 95% and the Zβ value = 0.84 with a power of 80%, two arms and a dropout rate of 30% at least 40 participants should be recruited. A consecutive sampling will be applied and allocated randomly using the simple randomization technique.
  17. Proposed Statistical Analysis Data on the effect of robotic mirror therapy compared to conventional mirror therapy will be assessed using the independent t-test. Data from the FMA-UE and NHPT assessments before and after the intervention will be analyzed using the paired t-test. Next, the relationship between the FMA-UE and NHPT values will be assessed using the Pearson correlation test (normally distributed data) or the Spearman test (data not normally distributed) to determine how big the correlation is between these variables.
Being tested
SYREBO, Conventional Mirror Method
Keywords
Robotic Therapy, Mirror Therapy, Post-Stroke, Upper Extremities, Motoric Function, Functional Outcome
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYREBOProcedure or surgery

    Serial ADL training of upper extremities with robotic aid

  • Conventional Mirror MethodProcedure or surgery

    Serial ADL training of upper extremities assisted by physical therapist

Study groups in NCT06155058
Study groupRoleWhat they receive
Robotic Mirror TherapyExperimentalSerial training with the help of exoskeletal robot therapy
Receives: Procedure: SYREBO
Conventional Mirror TherapyActive comparatorSerial training with the help of physical therapist
Receives: Procedure: Conventional Mirror Method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FMA-UE Score

    a motoric assessment with each score range from 0-2 with a total score range from 0-66. Higher score indicates better and free movement

    Measured: changes of FMA-UE score from pre-intervention to six weeks after intervention

  2. NHPT value

    an assessment for finger dexterity and coordination where the time of the subject to accomplish task will be recorded. Average healthy adult male completed the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy adult women, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hands, respectively.

    Measured: changes of NHPT values from pre-intervention to six weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion30 Mar 2024 (estimated)

Resources

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
Model description
The intervention group will be the robotic and the active comparator will be the conventional mirror therapy exercise group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06155058
Sponsor's protocol ID
2411232122
Status last verified
Nov 2023
First submitted
24 Nov 2023
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect the confidentiality, should the data need to share, any de-identified data will be shared for peer-review

Publications

  • Beom J, Koh S, Nam HS, Kim W, Kim Y, Seo HG, Oh BM, Chung SG, Kim S. Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms. J Vis Exp. 2016 Aug 15;(114):54521. doi: 10.3791/54521.

    PubMed 27583794

  • Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

    PubMed 3809245

  • Chowdhury, Z., 2018. Effectiveness of Mirror Therapy on hand function improvement among patients with chronic stroke. IOSR Journal of Nursing and Health Science (IOSR-JNHS) e-ISSN: 2320-1959.p- ISSN: 2320-1940 Volume 4, Issue 6 Ver. V (Nov. - Dec. 2015), PP 01-04

  • Hijikata N, Kawakami M, Ishii R, Tsuzuki K, Nakamura T, Okuyama K, Liu M. Item Difficulty of Fugl-Meyer Assessment for Upper Extremity in Persons With Chronic Stroke With Moderate-to-Severe Upper Limb Impairment. Front Neurol. 2020 Nov 16;11:577855. doi: 10.3389/fneur.2020.577855. eCollection 2020.

    PubMed 33304304

  • Lee MM, Cho HY, Song CH. The mirror therapy program enhances upper-limb motor recovery and motor function in acute stroke patients. Am J Phys Med Rehabil. 2012 Aug;91(8):689-96, quiz 697-700. doi: 10.1097/PHM.0b013e31824fa86d.

    PubMed 22469877

  • Nogueira NGHM, Parma JO, Leao SESA, Sales IS, Macedo LC, Galvao ACDR, de Oliveira DC, Murca TM, Fernandes LA, Junqueira C, Lage GM, Ferreira BP. Mirror therapy in upper limb motor recovery and activities of daily living, and its neural correlates in stroke individuals: A systematic review and meta-analysis. Brain Res Bull. 2021 Dec;177:217-238. doi: 10.1016/j.brainresbull.2021.10.003. Epub 2021 Oct 7.

    PubMed 34626693

  • Rothgangel AS, Braun SM, Beurskens AJ, Seitz RJ, Wade DT. The clinical aspects of mirror therapy in rehabilitation: a systematic review of the literature. Int J Rehabil Res. 2011 Mar;34(1):1-13. doi: 10.1097/MRR.0b013e3283441e98.

    PubMed 21326041

  • Schrader M, Sterr A, Kettlitz R, Wohlmeiner A, Buschfort R, Dohle C, Bamborschke S. The effect of mirror therapy can be improved by simultaneous robotic assistance. Restor Neurol Neurosci. 2022;40(3):185-194. doi: 10.3233/RNN-221263.

    PubMed 35848045

Questions about this trial

What is this clinical trial studying?

A study testing SYREBO and Conventional Mirror Method in people with Stroke and Physical Disability, run by Hasanuddin University at 3 sites in Indonesia.

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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 4 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 3 sites in Indonesia. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Steven Kurniawan, MD (+6281319912162, stvn.aupp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FMA-UE Score (time frame: changes of FMA-UE score from pre-intervention to six weeks after intervention). 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?

On the ClinicalTrials.gov record for NCT06155058, which also lists 8 linked publications.

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 4 Dec 2023.

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