HandHANDREHPREDICTNCT07522060
Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
An observational study of Hand and Hand Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand, Hand Therapy, Upper Extremity
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 1 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with hand and upper extremity pathologies under the clinical responsibility of the principal investigator at Hacettepe University Faculty of Physical Therapy and Rehabilitation, Ankara, Turkey. Consecutive, non-probability sampling applied: all eligible patients enrolled in order of presentation until minimum n=60 is reached
Who may be able to join
- 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
- Able to provide written informed consent
Who cannot join
- • 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
- Refusal to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Physical Therapy and Rehabilitation
Ankara, 06100
Cigdem Ayhan Kuru, Professor, 00903123051576, cayhan@hacettepe.edu.tr
About this study
Official title: Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Clinician-Developed Digital Monitoring System
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.
Read the detailed description
The study addresses three research questions: (1) predictive power of early functional response for later clinical outcomes across four cascaded models (M1-M4), (2) classification of patient recovery profiles, and (3) measurement of clinical decision variation. System and methodological details reported in study supplement.
- Conditions
- Hand, Hand Therapy, Upper Extremity, Prediction Models, Hand Injuries, Hand Injuries and Disorders
- Keywords
- digital health monitoring, real-world evidence, clinical decision support, upper extremity rehabilitation, early response prediction
- Medical subject headings
- Hand Injuries, Disease, Tendon Injuries, Wrist Fractures, Carpal Tunnel Syndrome, Peripheral Nerve Injuries, Wrist Injuries, Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hand Rehabilitation Cohort | Adults with hand and upper extremity pathologies undergoing rehabilitation under the clinical responsibility of the principal investigator at Hacettepe University Faculty of Physical Therapy and Rehabilitation. Consecutive sampling: all eligible patients enrolled in order of presentation until minimum sample size is reached. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: PROM Data Completeness
Proportion of rehabilitation sessions with complete PROM data entries throughout the study period. Success criterion: ≥85% completeness rate.
Measured: Throughout the 12-month study period
Model M1: Session-Based Early Response → Session 12
Predictive Power of Sessions 1-4 Functional Change (ΔS₁-₄) for Session 12 Outcome Association between the early response score (ΔS₁-₄ = mean change in primary PROM per session during sessions 1-4) and primary PROM score at session 12, assessed via linear regression and ROC curve analysis (AUC). Baseline PROM entered as covariate.
Measured: Baseline (session 1) to session 12 (approximately 4-8 weeks)
Model M2: Month 1 Change → Month 3 Outcome
Predictive Power of 1-Month Change (Δ₀→₁) for 3-Month Outcome Association between change in primary PROM from baseline to 1-month assessment and PROM score at 3 months, with covariate adjustment for baseline severity. Tests whether early-period change forecasts mid-term outcomes.
Measured: Baseline to 3-month standardized assessment
Model M4: Month 1 Change → Month 6 Outcome
Predictive Power of 1-Month Change (Δ₀→₁) for 6-Month Outcome Association between change in primary PROM from baseline to 1-month assessment and PROM score at 6 months. This is the primary cascaded prediction model: can a single early assessment predict medium-to-long-term functional outcomes? Findings will inform evidence-based treatment modification thresholds.
Measured: Baseline to 6-month standardized assessment
Secondary outcomes (6)
Model M3: Month 3 Change → Month 6 Outcome
Predictive Power of 3-Month Change (Δ₀→₃) for 6-Month Outcome Association between change in primary PROM from baseline to 3-month assessment and PROM score at 6 months, with baseline covariate adjustment. Completes the cascaded prediction chain (M1-M4).
Measured: Baseline to 6-month standardized assessment
Recovery Profile Classification
Number of Distinct Longitudinal Recovery Profiles Number of meaningfully different recovery trajectory clusters identified via K-means clustering of longitudinal PROM data (silhouette analysis for optimal cluster number) and individual growth curves from linear mixed models.
Measured: Baseline through session 12 (~4-8 weeks)
Clinical Decision Variation
Treatment Protocol Variation Coefficient (CV%) Coefficient of variation (CV%) of treatment protocol codes applied to patients with similar diagnostic and baseline profiles (IQR grouping), and Spearman correlation between protocol variation index and session 12 functional outcome.
Measured: Throughout the 12-month study period
Feasibility: Clinician Acceptance
Clinician Acceptance Rate Proportion of clinicians a rating system usability as acceptable or above (≥4/5) on a structured 5-item Likert questionnaire. Success criterion: ≥80% acceptance rate.
Measured: At 3 months and 12 months
MCID Responder Rate
Proportion Achieving MCID at Each Milestone Proportion of patients whose primary PROM change from baseline exceeds the established MCID threshold at each milestone (1, 2, 3, 6, 9, 12 months). Scale-specific MCID values: DASH=10.0; QuickDASH=15.9; PRWE=11.5; MHQ=12.8; Boston CTS=0.74; PSFS=2.0.
Measured: Monthly from baseline to 12 months
Feasibility: Milestone Completion Rate
Standardized Assessment Milestone Completion Rate Proportion of scheduled milestone assessments (baseline, 1, 2, 3, 6, 9, 12 months) completed within ±2 weeks of the target date. Success criterion: ≥80% completion rate.
Measured: Throughout the 12-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Jun 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cigdem Ayhan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522060
- Sponsor's protocol ID
- HU-HANDREHAB-2026
- Acronym
- HANDREHPREDICT
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared to protect privacy. Aggregate data and complete R analysis code will be made available as supplementary material upon publication. De-identified study data may be made available upon reasonable written request to the corresponding author following publication.