NCT07884825

Brief Summary

Carpal tunnel syndrome (CTS) is a common condition caused by compression of the median nerve at the wrist. It may cause pain, numbness, tingling, reduced hand function, decreased grip strength, and impaired quality of life. This randomized controlled trial compared the effects of a technology-assisted multimodal rehabilitation program with conventional physiotherapy in adults with mild-to-moderate carpal tunnel syndrome. A total of 40 participants were randomly allocated to two groups. The technology-assisted rehabilitation group used the ErgoActive system with Leap Motion sensor technology, while the conventional physiotherapy group received conventional physiotherapy. Both groups received 18 treatment sessions over six weeks. The primary outcome was symptom severity, assessed using the Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-SSS). Secondary outcomes included pain intensity, functional status, hand-related quality of life, and grip strength. Pain was assessed using a visual analogue scale (VAS), functional status using the Functional Status Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-FSS), hand-related quality of life using the Michigan Hand Outcomes Questionnaire (MHQ), and grip strength using a grip strength measurement device. All outcomes were assessed before and after the treatment period. The study aimed to determine whether technology-assisted multimodal rehabilitation provides greater improvements in symptoms, pain, hand function, grip strength, and hand-related quality of life than conventional physiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 21, 2026

Completed
Last Updated

October 21, 2026

Status Verified

October 1, 2026

Enrollment Period

9 months

First QC Date

October 13, 2026

Last Update Submit

October 13, 2026

Conditions

Keywords

Carpal tunnel syndrometechnology-assisted rehabilitationvirtual rehabilitationhand functionphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Symptom Severity Assessed Using the Boston Carpal Tunnel Questionnaire (BCTQ-SSS)

    The Symptom Severity Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-SSS) was used to assess the severity of carpal tunnel syndrome symptoms. The measure was assessed at baseline and after completion of the six-week intervention period.

    Baseline to immediately after the 6-week intervention period

Study Arms (2)

Technology-Assisted Multimodal Rehabilitation Group (TARG)

EXPERIMENTAL

Participants in this group received a technology-assisted multimodal rehabilitation program using the ErgoActive system with Leap Motion sensor technology. The intervention consisted of 18 sessions delivered over six weeks for individuals with mild-to-moderate carpal tunnel syndrome. Outcomes were assessed at baseline and after completion of the intervention.

Device: Technology-Assisted Multimodal Rehabilitation Group (TARG)

Conventional Physiotherapy Group (CPG)

ACTIVE COMPARATOR

Participants in this group received conventional physiotherapy for mild-to-moderate carpal tunnel syndrome. The intervention consisted of 18 treatment sessions over six weeks. Outcomes were assessed at baseline and after completion of the intervention period. The results of this group were compared with those of the technology-assisted multimodal rehabilitation group.

Other: Conventional Physiotherapy Group (CPG)

Interventions

Participants assigned to the conventional physiotherapy group received conventional physiotherapy for mild-to-moderate carpal tunnel syndrome. The intervention consisted of 18 sessions delivered over six weeks. Outcomes were assessed before and after the intervention.

Conventional Physiotherapy Group (CPG)

Participants assigned to the technology-assisted rehabilitation group received a multimodal rehabilitation program using the ErgoActive system with Leap Motion sensor technology for individuals with mild-to-moderate carpal tunnel syndrome. The intervention consisted of 18 sessions delivered over six weeks. Outcomes were assessed before and after the intervention.

Technology-Assisted Multimodal Rehabilitation Group (TARG)

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals aged 35-55 years diagnosed with mild to moderate Carpal Tunnel Syndrome (CTS) at Rami Hospital who are able to engage with the Ergo Active rehabilitation system using Leap Motion sensors and artificial intelligence-based applications.
  • Medically and clinically stable at the time of assessment and Ability to understand and follow verbal instructions and perform guided ergonomics exercises using the Ergo Active system.
  • Willingness to participate in the study and provide written informed consent

You may not qualify if:

  • Inability to comply with the study protocol due to cognitive, visual, or physical limitations.
  • Severe Carpal Tunnel Syndrome symptoms VAS scale more than 8 in last 6 months or any neurological or musculoskeletal disorders affecting the upper limbs
  • Prior surgical intervention for CTS less than 5 years or concurrent participation in any other rehabilitation program during the study period.
  • Presence of systemic diseases, such as uncontrolled diabetes mellitus or thyroid dysfunction, that could influence the study outcomes.
  • Pregnancy or lactation, which may alter nerve conduction and affect study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Rami Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This randomized controlled trial used a two-arm, parallel-group design. Participants were randomly allocated to either the technology-assisted multimodal rehabilitation group or the conventional physiotherapy group. Both groups received 18 treatment sessions over six weeks. Outcomes were assessed at baseline and immediately after the intervention period.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 13, 2026

First Posted

October 21, 2026

Study Start

May 15, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

October 21, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly to protect participant privacy and confidentiality. The study data will be handled in accordance with applicable ethical requirements and data protection regulations.

Locations