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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tendon Injuries; Wrist Injuries; Finger Injuries; Hand Injuries; Trigger Finger; Peripheral Nerve Injuries; DeQuervain's Tenosynovitis; Cubital Tunnel Syndrome; Carpal Tunnel Syndrome (CTS); Prediction Models; Wrist Fractures; Hand Injuries and Disorders; Upper Extremity; Hand; Hand Arthritis; Hand Therapy; Trapeziometacarpal (TMC) Arthrosis; Upper Extremity Injuries; Postoperative Rehabilitation

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Cigdem Ayhan Kuru, Professor; Phone Number: 00903123051576; Email: cayhan@hacettepe.edu.tr

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe University Faculty of Physical Therapy and Rehabilitation
    • Contact: Cigdem Ayhan Kuru, Professor; Phone Number: 00903123051576; Email: cayhan@hacettepe.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: PROM Data Completeness	Proportion of rehabilitation sessions with complete PROM data entries throughout the study period. Success criterion: ≥85% completeness rate.	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.	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.	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.	Baseline to 6-month standardized assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	Throughout the 12-month study period

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: clinical decision support; real-world evidence; digital health monitoring; upper extremity rehabilitation; early response prediction
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Peripheral Nervous System Diseases; Fractures, Bone; Trauma, Nervous System; Arm Injuries; Tendinopathy; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Ulnar Neuropathies; Tendon Entrapment; Ulnar Nerve Compression Syndromes; Pathological Conditions, Signs and Symptoms; Wrist Fractures; Osteoarthritis; Disease; Wrist Injuries; Carpal Tunnel Syndrome; Hand Injuries; Peripheral Nerve Injuries; Tendon Injuries; Trigger Finger Disorder; Cubital Tunnel Syndrome; Finger Injuries
• Other Study ID Numbers: HU-HANDREHAB-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No