Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHacettepe University

About this trial

This study investigates whether early changes observed during the first weeks of hand and upper extremity rehabilitation can predict patient outcomes months later. In rehabilitation practice, clinicians make numerous decisions each session regarding exercise type, frequency, duration, and treatment approach. Most of these decisions are currently made without systematic longitudinal data. This study addresses three fundamental questions using data collected during routine clinical care: (1) Can the rate of improvement in the first weeks of treatment predict functional status months later, across both session-based and milestone-based time points? (2) Are there meaningfully different recovery profiles among hand rehabilitation patients? (3) Is there measurable variation in clinical decision-making among patients with similar profiles, and does this variation relate to outcomes? A digital patient monitoring platform developed by the principal investigator, a physiotherapist and academic researcher specializing in hand rehabilitation serves as the data collection infrastructure. The platform records standard clinical assessment measures in a structured format and has been in active clinical use at Hacettepe University prior to this study. For research purposes, the system has been expanded to include structured capture of patient-reported outcomes, patient global impression of change, treatment protocol coding, home exercise adherence, and automated calculation of early response metrics.

This is a 12-month prospective observational cohort study enrolling a minimum of 60 patients. Data are stored securely on the university's institutional network. Patients are anonymized using identification codes. The study is subject to Hacettepe University Ethics Committee approval and participant informed consent. Findings are expected to generate evidence supporting data-driven clinical decision-making in rehabilitation and to provide a feasibility foundation for a larger multi-center study.

Eligibility criteria

Qualifiers

Adults aged 18 years or older

Hand or upper extremity pathology requiring rehabilitation, including but not limited to: flexor or extensor tendon injuries, peripheral nerve injuries or compression syndromes (including carpal tunnel syndrome, cubital tunnel syndrome), distal radius fractures, metacarpal or phalangeal fractures, joint injuries and instabilities, arthropathy (osteoarthritis, rheumatoid arthritis), trapeziometacarpal osteoarthritis, trigger finger, Dupuytren's disease, DeQuervain tenosynovitis, lateral epicondylitis and post-surgical upper extremity conditions

Under clinical responsibility of the principal investigator at the Faculty of Physical Therapy and Rehabilitation, Hacettepe University

Expected to attend minimum 8 rehabilitation sessions

Disqualifiers

• Active psychiatric illness precluding participation or completion of assessment tools

Severe cognitive impairment precluding understanding of patient-reported outcome measures

Literacy difficulties preventing self-completion of questionnaires

Concurrent enrollment in another interventional clinical study

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

60 Participants
are grouped into 1 trial group

Sponsors and collaborators