Carpal Tunnel Syndrome (CTS)TECH-CTS-REHABNCT07884825
Effects of Technology-Assisted Rehabilitation on Pain and Hand Function in People With Carpal Tunnel Syndrome
A study testing Technology-Assisted Multimodal Rehabilitation Group (TARG) and Conventional Physiotherapy Group (CPG) in people with Carpal Tunnel Syndrome (CTS), run by Hüseyin Melih Göktuğ Akpulat at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Technology-Assisted Multimodal Rehabilitation Group (TARG) and Conventional Physiotherapy Group (CPG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Technology-Assisted Multimodal Rehabilitation Program on Pain, Hand Function, Grip Strength, and Hand-Related Quality of Life in Individuals With Carpal Tunnel Syndrome
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Technology-Assisted Multimodal Rehabilitation Group (TARG), Conventional Physiotherapy Group (CPG)
- Keywords
- Carpal tunnel syndrome, technology-assisted rehabilitation, virtual rehabilitation, hand function, physiotherapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-Assisted Multimodal Rehabilitation Group (TARG)Device
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.
Conventional Physiotherapy Group (CPG)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional Physiotherapy Group (CPG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to immediately after the 6-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 May 2025
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hüseyin Melih Göktuğ Akpulat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hüseyin Melih Göktuğ Akpulat, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884825
- Sponsor's protocol ID
- TECH-REHAB-CTS
- Acronym
- TECH-CTS-REHAB
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Technology-Assisted Multimodal Rehabilitation Program on Pain, Hand Function, Grip Strength, and Hand-Related Quality of Life in Individuals With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT07884825
- Acronym / sponsor ID
- TECH-CTS-REHAB / TECH-REHAB-CTS
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- Carpal tunnel syndrome, technology-assisted rehabilitation, virtual rehabilitation, hand function, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hüseyin Melih Göktuğ AkpulatUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Technology-Assisted Multimodal Rehabilitation Group (TARG) | Experimental | Device: Technology-Assisted Multimodal Rehabilitation Group (TARG)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. |
| Conventional Physiotherapy Group (CPG) | Active comparator | Other: Conventional Physiotherapy Group (CPG)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. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology-Assisted Multimodal Rehabilitation Group (TARG)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. | Device | Technology-Assisted Multimodal Rehabilitation Group (TARG) |
| Conventional Physiotherapy Group (CPG)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. | Other | Conventional Physiotherapy Group (CPG) |
Primary outcome
Symptom Severity Assessed Using the Boston Carpal Tunnel Questionnaire (BCTQ-SSS)
Time frame: Baseline to immediately after the 6-week intervention period
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-Assisted Multimodal Rehabilitation Group (TARG) and Conventional Physiotherapy Group (CPG) in people with Carpal Tunnel Syndrome (CTS), run by Hüseyin Melih Göktuğ Akpulat at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Severity Assessed Using the Boston Carpal Tunnel Questionnaire (BCTQ-SSS) (time frame: Baseline to immediately after the 6-week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.