Skip to content

Determining the effectiveness of the FEPSim™ device for hand therapy

Determining the effectiveness of a new device for hand therapy: the FEPSim™ device

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13656014
Enrollment
104
Registered
2020-06-04
Start date
2020-04-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Limitations in forearm, wrist, or hand function due to distal radial/ulnar fractures, stroke, or osteoarthritis Musculoskeletal Diseases

Interventions

The intervention group will receive the same standard care as the control group at each hospital, which consists of immobilization for 7-8 weeks after the time of the injury or surgery, followed by ha

Sponsors

University of Alberta
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients: 1. Wrist fractures, acquired brain injuries, burns or osteoarthritis (e.g. patients who have undergone a Wrist Salvage Procedure), causing limitation in hand movement 2. 18 years of age and older Therapists: 3. The therapists need to have used the FEPSim™ to be able to provide feedback about the usability of the device during the interview

Exclusion criteria

Exclusion criteria: 1. Chronic Regional Pain Syndrome 2. Subjective/patient-reported limitation to participate (e.g. excessive pain, edema) 3. Limitations in reading and listening comprehension of language that prohibits to understand the PRWE questionnaire 4. Limitation in following instructions due to cognitive impairment

Design outcomes

Primary

MeasureTime frame
At week 0 and after the intervention (week 10), and during weeks 4 and 8: 1. Angles of active range of motion (AROM) and passive range of motion (PROM) of wrist flexion and extension, and forearm pronation and supination, measured using a goniometer 2. Grip strength measured using a grip dynamometer 3. Pinch grip force is measured using a pinch gauge or pinch meter

Secondary

MeasureTime frame
At week 0 and after the intervention (week 10), and during weeks 4 and 8: Patients’ perceived wrist pain and disability in activities of daily living measured using the Patient-Rated Wrist Evaluation (PRWE)

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026