An observational study in Hand, Hand Therapy and Upper Extremity, sponsored by Hacettepe University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Hacettepe University · Observational
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.
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.
24 studies on the registry are indexed under Finger Injuries; 4 are open to participants now.
Browse Finger Injuries studies →Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.
Compared within Finger Injuries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hand Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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
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Exclusion Criteria:
Active psychiatric illness precluding participation or completion of assessment tools
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Feasibility: PROM Data Completeness
Proportion of rehabilitation sessions with complete PROM data entries throughout the study period. Success criterion: ≥85% completeness rate.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6-month standardized assessment
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Throughout the 12-month study period
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Dec 2026, 6 months later.
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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