The clinical utility of robotic-assisted therapy in the treatment of post-stroke shoulder pain
| ISRCTN | ISRCTN13455548 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13455548 |
| Secondary identifying numbers | REC/09/2022 (ST/FB/12) |
- Submission date
- 20/02/2025
- Registration date
- 24/02/2025
- Last edited
- 24/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Hemiplegic shoulder pain (HSP) is a common issue for stroke survivors. This study aims to explore how effective a robotic device is in reducing HSP pain by comparing robotic-assisted therapy to conventional treatment.
Who can participate?
The study will involve stroke survivors with shoulder pain.
What does the study involve?
Participants will be randomly assigned to one of two groups. One group will receive standard rehabilitation therapy, while the other group will receive the same therapy combined with robotic-assisted training using the ArmMotus M2 device. Evaluators, who do not know which group participants are in, will measure shoulder pain and range of motion before and after the intervention.
What are the possible benefits and risks of participating?
Participants in the robotic therapy group are expected to experience meaningful reductions in pain scores, while those in the conventional therapy group are expected to see significant improvements in shoulder movements. As with any therapy, there may be risks, but these are not specified in the study details.
Where is the study run from?
Universiti Teknologi MARA (Malaysia)
When is the study starting and how long is it expected to run for?
September 2022 to September 2023.
Who is funding the study?
Universiti Teknologi MARA (Malaysia)
Fourier Intelligence (Malaysia)
Who is the main contact?
Dr Natiara Mohamad Hashim, natiara_hashim@yahoo.com
Contact information
Public, Scientific, Principal Investigator
No 56,Jalan Pulau Lumut 76E/U10
Taman Alam Budiman
Shah Alam
40170
Malaysia
 ORCID ID |
0000-0002-6466-2551 |
|---|---|
| Phone | +60 193803105 |
| natiara@uitm.edu.my |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Efficacy |
| Participant information sheet | 46876 REC4_Participant Information Sheet.do_fourier (V3).pdf |
| Scientific title | The clinical utility of robotic assisted therapy in the management of hemiplegic shoulder pain: a pilot randomized control study |
| Study objectives | We hypothesize that the end- effector robotic device can provide adequate range of motion exercise that includes protraction and retraction, forward flexion, internal and external of shoulder joint movement, that helps to increase flexibility and reduce stiffness, that contributing to the shoulder pain. It also provides immersive interactive experiences through gaming that simulate various degrees of resistance, inertial force and elasticity that provide strengthening exercise that helps to increase the strength of the shoulder girdle muscle and increase patient participation towards exercise. |
| Ethics approval(s) |
Approved 05/09/2022, UiTM RESEARCH ETHICS COMMITTEE (Universiti Teknologi MARA,Aras 3, Bangunan Wawasan, Shah Alam, 55442004, Malaysia; +60 355442004; recsecretariat@uitm.edu.my), ref: REC/08/2022 (FB/36) |
| Health condition(s) or problem(s) studied | Treatment of post-stroke shoulder pain |
| Intervention | Patients allocated to the intervention group underwent a comprehensive pre-intervention assessment before commencing the robot-assisted therapy. The therapy involved utilising the ArmMotus M2 for robot-assisted training, accompanied by physical modalities consistent with those received by the control conventional group. The duration of the treatment ranged from 45 minutes to 1 hour, with the robotic-assisted training specifically lasting 30 minutes, interspersed with 5-minute rest periods as needed. Each patient was seated in a chair, and their affected upper limb was secured to the robot arm using straps. Initially, participants commenced the training in robot-assistive mode to gauge their initial performance and motor severity level. The ArmMotus M2 provided task-oriented training incorporating bio-sensory feedback through interactive games. As the therapy progressed, the game's difficulty level was adjusted based on the patient’s performance, transitioning from passive-partially assistive to active-resistive modes. In the passive mode, the robot moved the arm without active participation from the patient, whereas in the active mode, the patient moved the arm entirely if capable. If a patient was unable to perform actively due to post-stroke weakness, the robot-assisted in moving the arm during the therapy. The therapy would cease immediately if a patient reported any pain or exhaustion. A total of 12 sessions were scheduled to be completed within a 3–4-week period, followed by post-intervention assessments upon completion of the therapy. On occasions where participants are unable to fulfil this requirement within the stipulated duration, they will be considered dropouts. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | ArmMotus2 |
| Primary outcome measure | Pain at baseline using VAS at baseline and upon completion of therapy at 3-4 weeks |
| Secondary outcome measures | Range of motion measured clinically at baseline and upon completion of therapy at 3-4 weeks |
| Overall study start date | 05/09/2022 |
| Completion date | 25/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 24 |
| Total final enrolment | 24 |
| Key inclusion criteria | 1. Individuals who had experienced stroke 2. Presented with hemiplegia who scored Motor Assessment Scale score of 0 to 4 on item 6 3. Reported shoulder pain localised around the shoulder girdle muscles, glenohumeral joint, bicipital groove, or acromial clavicular area during passive shoulder range of motion, with a minimum Numerical Pain Rating Scale (NPRS) score of 3 |
| Key exclusion criteria | 1. Diminished cognitive function as assessed by an Mini Mental State Examination score of less than 23 2. Individuals with severely restricted shoulder range of motion (limited to 20 degrees across all motions) 3. Shoulder joint contractures or the presence of significant heterotrophic ossification |
| Date of first enrolment | 10/09/2022 |
| Date of final enrolment | 12/07/2023 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Selangor
42300
Malaysia
Sponsor information
University/education
Faculty of Medicine, Kampus Sungai Buloh, Jalan Hospital, Sungai Buloh
Petaling
47000
Malaysia
| Phone | +60 361265000 |
|---|---|
| dmemedic@uitm.edu.my | |
| Website | https://uitm.edu.my |
Funders
Funder type
Industry
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- Universiti Teknologi MARA - UiTM, MARA Technological University, Universiti Teknologi MARA (UITM), Universiti Teknologi MARA in Malaysia, Universiti Teknologi MARA MIMI, Universiti Teknologi MARA | Shah Alam, Malaysia | UiTM, Universiti Teknologi MARA, Malaysia, Universiti Teknologi Mara (UiTM), Malaysia, UiTM – Universiti Teknologi MARA, Universiti Teknologi MARA (UiTM) (Klang, Malaysia), UiTM - Universiti Teknologi MARA, Universiti Teknologi MARA Malaysia, اونيۏرسيتي تيكنولوڬي مارا, University of Technology MARA, UiTM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 07/09/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Natiara Mohamad Hashim, natiara_hashim@yahoo.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 24/02/2025 | No | Yes |
Additional files
Editorial Notes
21/02/2025: Trial's existence confirmed by UiTM RESEARCH ETHICS COMMITTEE.
