Safety trial of a locally-developed trunk and lower limb rehabilitation robot
| ISRCTN | ISRCTN12604075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12604075 |
| Secondary identifying numbers | AHMC 2023-01 |
- Submission date
- 17/01/2025
- Registration date
- 24/01/2025
- Last edited
- 23/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The TAYO project aims to improve physical therapy care using a device called the Lower Limb Mobilization (LLMo). This device helps physical therapists perform passive range of motion exercises for people in the early stages of recovery after a stroke.
Who can participate?
Healthy individuals aged 18 to 65 years old.
What does the study involve?
Participants will perform range of motion exercises using the LLMo device. During the trial, their vital signs, comfort, and pain levels will be continuously monitored to ensure the device's safety.
What are the possible benefits and risks of participating?
Participants may feel some stretching in their lower extremities. Although the device is external and does not exchange energy with the patient, there is a risk associated with the device moving the participants' limbs. The device has passed rigorous mechanical and electrical tests to ensure safety.
Where is the study run from?
The study is conducted at the De La Salle University - Laguna Campus research lab (Philippines)
When is the study starting and how long is it expected to run for?
March 2023 to June 2023
Who is funding the study?
The study is funded by the Department of Science and Technology - Philippine Council for Health Research and Development (DOST-PCHRD)
Who is the main contact?
Engr. Julius Banayo, julius.banayo@dlsu.edu.ph
Contact information
Principal Investigator
2401 Taft Ave.
Manila
922
Philippines
 ORCID ID |
0009-0005-4838-2735 |
|---|---|
| Phone | +63 9177748816 |
| armyn.sy@dlsu.edu.ph |
Public, Scientific
727V+352, LTI Spine Road, Laguna Blvd
Biñan, Laguna
4024
Philippines
| Phone | +63 9162870211 |
|---|---|
| julius.banayo@dlsu.edu.ph |
Study information
| Study design | Interventional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | University/medical school/dental school |
| Study type | Safety |
| Participant information sheet | No participant information sheet available |
| Scientific title | A pilot study among normal subjects on the safety and functionality of a locally-developed trunk and lower limb rehabilitation robot |
| Study objectives | The lower limb rehabilitation robot is safe to use among healthy participants |
| Ethics approval(s) |
Approved 23/03/2023, Asian Hospital and Medical Center Research Ethics Committee (2205 Civic Dr, Muntinlupa, Metro Manila, 1780, Philippines; +63 (02) 8771 9000; info@asianhospital.com), ref: AHMC 2023-01 |
| Health condition(s) or problem(s) studied | Passive range of motion among healthy adult participants |
| Intervention | After meeting the inclusion criteria and medical evaluation, participants’ vital signs (blood pressure, heart rate, and oxygen saturation) and lower limb measurements were recorded prior to the trial. They were then secured to the Lower Limb Mobilization (LLMo) device and performed three repetitions of each prescribed lower limb exercise. Lower limb angles were measured after each repetition. Throughout the exercises, the attending physiatrist and physiotherapist consistently monitored the participants, sought feedback and pain assessments from participants. Following the exercises, participants' vital signs were recorded before, during and at end of exercise. Additionally, they were given a survey to assess their perceptions of the LLMo’s safety, feasibility, and acceptability while performing exercises. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase 0 |
| Drug / device / biological / vaccine name(s) | Lower Limb Mobilization Device (LLMo Device) |
| Primary outcome measure | Safety evaluation: 1. Safety checklist used to inspect device before the trial 2. Pain assessment administered as needed during the exercises 3. Adverse events reported as needed throughout the entire trials |
| Secondary outcome measures | 1. Range of Motion of each exercise measured using goniometer at the end of each movement 2. Range of Motion of each exercise measured using device software at the end of each movement 3. Patient perception of safety, feasibility, and acceptability measured using a survey at the end of each session 4. Comments regarding comfort recorded verbally over the course of the whole exercise session; Physiatrist wrote down notes comments in participant chart |
| Overall study start date | 23/03/2023 |
| Completion date | 17/06/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 18 |
| Total final enrolment | 18 |
| Key inclusion criteria | 1. Be able to follow instructions 2. Be at least 5'4" (1.63 m) to 6'2" (1.87 m) 3. Weigh less than 200 kg 4. Have full use of their trunk and lower extremities 5. Agree to have medical clearance sponsored by the research prior to participation (validity: 1-2 weeks from appointed clinical study participation) 6. Be fully vaccinated against COVID-19 (2 completed doses, with or without boosters) |
| Key exclusion criteria | With any known disabilities or comorbidities |
| Date of first enrolment | 01/05/2023 |
| Date of final enrolment | 26/05/2023 |
Locations
Countries of recruitment
- Philippines
Study participating centre
Biñan, Laguna
4024
Philippines
Sponsor information
Research organisation
2401 Taft Ave.
Manila
922
Philippines
| Phone | +632 8524-4611 Local 360 |
|---|---|
| ibeht@dlsu.edu.ph | |
| Website | https://ibeht.com/home |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department of Science and Technology, Philippines Department of Science and Technology, Department of Science and Technology, Philippines, Kagawaran ng Agham at Teknolohiya, DOST
- Location
- Philippines
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2 | 10/02/2023 | 23/01/2025 | No | No |
Additional files
Editorial Notes
17/01/2025: Trial's existence confirmed by Asian Hospital and Medical Center Research Ethics Committee.
