Safety trial of a locally-developed trunk and lower limb rehabilitation robot

ISRCTN	ISRCTN12604075
DOI	https://doi.org/10.1186/ISRCTN12604075
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	AHMC 2023-01
Sponsor	DLSU - Evelyn D. Ang - Institute of Biomedical Engineering and Health Technology
Funder	Department of Science and Technology, Republic of the Philippines

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Armyn Sy
Principal investigator

2401 Taft Ave.
Manila
922
Philippines

ORCID ID	0009-0005-4838-2735
Phone	+63 9177748816
Email	armyn.sy@dlsu.edu.ph

Mr Julius Banayo
Public, Scientific

727V+352, LTI Spine Road, Laguna Blvd
Biñan, Laguna
4024
Philippines

Phone	+63 9162870211
Email	julius.banayo@dlsu.edu.ph

Study information

Primary study design	Interventional
Study design	Interventional non-randomized
Secondary study design	Non randomised study
Study type	Participant information sheet
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
Phase	Phase 0
Drug / device / biological / vaccine name(s)	Lower Limb Mobilization Device (LLMo Device)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
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	All
Target sample size at registration	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

De La Salle University - Laguna Campus

727V+352, LTI Spine Road, Laguna Blvd
Biñan, Laguna
4024
Philippines

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 2	10/02/2023	23/01/2025	No	No

Additional files

46696 TAYÔ CLINICAL TRIAL PROTOCOL v2 10Feb2023.pdf: Protocol file

Editorial Notes

17/01/2025: Trial's existence confirmed by Asian Hospital and Medical Center Research Ethics Committee.