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

NCT07522060 | Not Yet Recruiting

• 1 other identifier: HU-HANDREHAB-2026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hand; Hand Therapy; Upper Extremity; Prediction Models; Hand Injuries; Hand Injuries and Disorders; Hand Arthritis; Upper Extremity Injuries; Wrist Injuries; Finger Injuries; Trigger Finger; Trapeziometacarpal (TMC) Arthrosis; DeQuervain's Tenosynovitis; Cubital Tunnel Syndrome; Tendon Injuries; Wrist Fractures; Carpal Tunnel Syndrome (CTS); Peripheral Nerve Injuries; Postoperative Rehabilitation

Keywords

digital health monitoring; real-world evidence; clinical decision support; upper extremity rehabilitation; early response prediction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Model M3: Month 3 Change → Month 6 Outcome

  Baseline to 6-month standardized assessment

• Recovery Profile Classification

  Baseline through session 12 (~4-8 weeks)

• Clinical Decision Variation

  Throughout the 12-month study period

• Feasibility: Clinician Acceptance

  At 3 months and 12 months

• MCID Responder Rate

  Monthly from baseline to 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Physical Therapy and Rehabilitation

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hand Injuries; Disease; Tendon Injuries; Wrist Fractures; Carpal Tunnel Syndrome; Peripheral Nerve Injuries; Wrist Injuries; Finger Injuries; Trigger Finger Disorder; Osteoarthritis; Cubital Tunnel Syndrome

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arm Injuries; Fractures, Bone; Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Trauma, Nervous System; Tendon Entrapment; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Ulnar Neuropathies; Ulnar Nerve Compression Syndromes

Central Study Contacts

Cigdem Ayhan Kuru, Professor

CONTACT

00903123051576; cayhan@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 13, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)