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

A pilot study among normal subjects on the safety and functionality of a locally-developed trunk and lower limb rehabilitation robot

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12604075
Enrollment
18
Registered
2025-01-24
Start date
2023-05-01
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Passive range of motion among healthy adult participants Not Applicable

Interventions

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

Sponsors

DLSU - Evelyn D. Ang - Institute of Biomedical Engineering and Health Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: With any known disabilities or comorbidities

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Philippines

Contacts

Public ContactJulius Banayo
julius.banayo@dlsu.edu.ph+63 9162870211

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026