An interventional study of Technology-Assisted Multimodal Rehabilitation Group (TARG) and Conventional Physiotherapy Group (CPG) in Carpal Tunnel Syndrome (CTS), sponsored by Hüseyin Melih Göktuğ Akpulat. Completed at 1 site in Turkey (Türkiye). Open to participants aged 35 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Hüseyin Melih Göktuğ Akpulat · Not applicable, Interventional, and Treatment
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.
This study was designed as a randomized controlled trial to compare a technology-assisted multimodal rehabilitation program with conventional physiotherapy in adults with mild-to-moderate carpal tunnel syndrome (CTS).
Study Design and Participants Forty adults with mild-to-moderate CTS participated in the study. Participants were randomly assigned to one of two groups: a technology-assisted rehabilitation group (TARG, n = 20) or a conventional physiotherapy group (CPG, n = 20). Both groups received 18 treatment sessions over a six-week period.
Interventions The technology-assisted rehabilitation group received a multimodal rehabilitation program using the ErgoActive system with Leap Motion sensor technology. The system was used to support rehabilitation activities involving hand movement and function.
The conventional physiotherapy group received conventional physiotherapy according to the study protocol.
Outcome Measures 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, assessed using a visual analogue scale (VAS). Functional status, assessed using the Functional Status Scale of the Boston Carpal Tunnel Questionnaire (BCTQ-FSS).
Hand-related quality of life, assessed using the Michigan Hand Outcomes Questionnaire (MHQ).
Grip strength, assessed using a grip strength measurement device. All outcomes were assessed at baseline and after completion of the six-week treatment period.
Statistical Analysis Between-group differences over time were evaluated using mixed analysis of variance (ANOVA). Analysis of covariance (ANCOVA), adjusting for baseline imbalances, was also performed to compare post-treatment outcomes between groups. Statistical significance was set according to the prespecified analysis plan.
Study Objective The objective was to determine whether a technology-assisted multimodal rehabilitation program produces greater short-term improvements in symptom severity, pain, functional status, grip strength, and hand-related quality of life than conventional physiotherapy in adults with mild-to-moderate CTS.
605 studies on the registry are indexed under Carpal Tunnel Syndrome; 138 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 457 interventional studies indexed under Carpal Tunnel Syndrome.
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Exclusion Criteria:
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)
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)
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.
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.
Symptom Severity Assessed Using the Boston Carpal Tunnel Questionnaire (BCTQ-SSS)
The Symptom Severity Scale (SSS) of the Boston Carpal Tunnel Questionnaire (BCTQ) was used to assess the severity of carpal tunnel syndrome symptoms, such as tingling, pain, and numbness. Each item is rated from 1 (no difficulty or mild symptoms) to 5 (severe symptoms or inability to perform). The scale score is reported as the mean item score, with a range of 1 to 5. Higher scores indicate more severe symptoms, meaning that lower scores reflect a better outcome. The scale was administered at baseline and after the six-week intervention period.
Time frame: Baseline to immediately after the 6-week intervention period
Plan to share: No — 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.
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Ran from May 2025 to primary completion in Feb 2026, 8 months.
Of 257 non-industry interventional studies with no phase under Carpal Tunnel Syndrome, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 27. This study's 8 months is below that.
Counting every sponsor, half of 267 studies reached it within 12 months; a quarter within 7 and three quarters within 27.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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