NCT07407036

Brief Summary

Scapholunate instability is a common form of carpal instability that can cause wrist pain, weakness, and functional limitations during daily activities. Conservative rehabilitation approaches are frequently recommended in the early stages; however, there is no standardized rehabilitation protocol, and the effects of different neuromuscular rehabilitation methods have not been sufficiently investigated. The primary aim of this study is to comparatively examine the effects of conventional physiotherapy approaches and virtual reality-supported neuromuscular rehabilitation on forearm muscle activation patterns assessed using surface electromyography, wrist proprioceptive function (joint position sense), pain intensity, and functional improvement in individuals with scapholunate instability, and to identify clinically applicable rehabilitation protocol approaches for this population. In this single-blind randomized controlled trial, participants with pre-dynamic or dynamic scapholunate instability will be randomly assigned to either a conventional rehabilitation group or a virtual reality-supported rehabilitation group. Both groups will receive an 8-week rehabilitation program administered twice per week. Primary outcome measures will include electromyographically assessed forearm muscle activation and wrist proprioception. Secondary outcome measures will include pain intensity, grip strength, wrist muscle strength, and upper extremity functional outcomes assessed using validated clinical instruments. All outcome assessments will be performed before and after the intervention period by an assessor blinded to group allocation.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Feb 2027

First Submitted

Initial submission to the registry

February 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

February 5, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

Scapholunate InstabilityWrist ProprioceptionSurface ElectromyographyNeuromuscular Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Wrist Proprioception

    Wrist proprioception will be assessed by evaluating joint position sense using both a universal goniometer and an electrogoniometer. Assessments will be performed in a standardized sitting position with the forearm supported. Predetermined wrist joint angles will be set by the assessor, and participants will be asked to actively reproduce the target positions without visual feedback. Wrist joint angles will be recorded using both measurement tools, and the absolute angular error between the target angle and the reproduced angle will be calculated to determine proprioceptive accuracy.

    Baseline and after 8 weeks of intervention

  • Forearm Muscle Activation

    Forearm muscle activation will be assessed using surface electromyography during standardized wrist and forearm tasks. Electromyographic activity of selected forearm muscles involved in wrist stabilization will be recorded and analyzed to evaluate neuromuscular activation patterns.

    Baseline and after 8 weeks of intervention

Secondary Outcomes (6)

  • Pain Intensity

    Baseline and after 8 weeks of intervention

  • Pressure Pain Threshold

    Baseline and after 8 weeks of intervention

  • Grip Strength

    Baseline and after 8 weeks of intervention

  • Wrist Muscle Strength

    Baseline and after 8 weeks of intervention

  • Upper Extremity Function (QuickDASH)

    Baseline and after 8 weeks of intervention

  • +1 more secondary outcomes

Study Arms (2)

Conventional Physiotherapy Group

ACTIVE COMPARATOR

Participants assigned to this arm will receive a structured conventional physiotherapy program focusing on wrist and forearm stabilization. The intervention will include strengthening exercises targeting scapholunate-friendly muscles, neuromuscular control exercises, and proprioceptive training aimed at improving wrist stability and functional movement patterns. The program will be delivered under supervision twice per week for 8 weeks.

Other: Conventional Physiotherapy Group

Virtual Reality-Supported Neuromuscular Rehabilitation Group

EXPERIMENTAL

Participants assigned to this arm will receive the same conventional physiotherapy program as the control group. In addition, they will participate in virtual reality-supported neuromuscular rehabilitation using sensor-based interactive therapeutic games designed for upper extremity rehabilitation. The virtual reality component will consist of four different game-based tasks targeting wrist and forearm motor control, proprioceptive feedback, and functional task performance. These games will be selected to promote controlled movement, coordination, and task-oriented motor training. The intervention will be administered twice per week for 8 weeks under physiotherapist supervision.

Other: Conventional Physiotherapy GroupOther: Virtual Reality-Supported Neuromuscular Rehabilitation

Interventions

Participants assigned to the conventional physiotherapy group will receive a structured neuromuscular rehabilitation program focusing on wrist and forearm stabilization. The intervention will include supervised strengthening exercises targeting scapholunate-friendly muscles, neuromuscular control exercises, and proprioceptive training aimed at improving wrist stability and functional movement patterns. Progressive resistance and task-oriented exercises will be used according to individual tolerance. The rehabilitation program will be administered twice per week for 8 weeks by a licensed physiotherapist.

Conventional Physiotherapy GroupVirtual Reality-Supported Neuromuscular Rehabilitation Group

Participants in the virtual reality-supported rehabilitation group will receive the same conventional physiotherapy program as the control group. In addition, this group will participate in virtual reality-based therapeutic exercises delivered through sensor-based interactive games designed for upper extremity rehabilitation. These exercises will aim to enhance wrist and forearm motor control, proprioceptive feedback, and functional task performance by promoting controlled and task-oriented movement patterns. Virtual reality sessions will be supervised by a physiotherapist and integrated into the rehabilitation program with the same frequency and duration as the conventional intervention, administered twice per week over an 8-week period.

Virtual Reality-Supported Neuromuscular Rehabilitation Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 65 years
  • Diagnosed with scapholunate instability (pre-dynamic or dynamic instability) by a physician and referred for conservative treatment
  • A score of ≤6 on the Beighton Hypermobility Scale
  • Presence of clinical instability symptoms, including pain, a sense of instability, and functional limitation
  • Willingness to participate in the study and high motivation to comply with the intervention protocol

You may not qualify if:

  • History of previous surgery involving the hand or wrist
  • Presence of any neurological or cardiovascular disorder
  • Presence of additional orthopedic pathology affecting the shoulder, elbow, or wrist other than scapholunate instability
  • History of surgery involving the ipsilateral upper extremity within the past 6 months
  • Presence of visual or hearing impairments that may interfere with participation in the rehabilitation program
  • Participation in sensory- or function-oriented rehabilitation of either hand within the past 6 months
  • A score below 26 on the Montreal Cognitive Assessment (MoCA)
  • Inability to read or write

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Zeynep HOSBAY, Professor

    Biruni University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

EDA URHUN KELES, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups: a conventional physiotherapy group or a virtual reality-supported neuromuscular rehabilitation group. Randomization will ensure that participants have an equal chance of being allocated to either group. Each participant will be assigned to a single study arm for the entire duration of the study and will not cross over to the other group. Both groups will receive conventional physiotherapy, while the intervention group will additionally receive virtual reality-supported neuromuscular rehabilitation. Both interventions will be delivered over an 8-week period with the same treatment frequency. Outcomes will be assessed before and after the intervention, and between-group comparisons will be performed to evaluate the effects of the two rehabilitation approaches.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 12, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations