ProprioceptionNCT04187677
Effect of Sensory Training on Activity Limitation, Functional Use of Hand and Quality of Life After Wrist Surgery
A study testing Sensory Training and classical hand therapy in people with Proprioception, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the benefits of sensory training for participants who are included in rehabilitation after carpal tunnel surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Proprioception
- What is being tested?
- Sensory Training and classical hand therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2018to 15 May 2020
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SANKO University Health Practice and Research Center, Orthopedics and Traumatology Unit underwent open carpal tunnel loosening surgery.
Who cannot join
- The presence of nerve entrapment other than the median nerve (any sensory / motor deficits in the ulnar or radial nerve),
- Wrist injury history (fractures, carpal instabilities),
- Previous surgery in the hand or wrist region,
- Traumatic and recurrent Carpal Tunnel Syndrome, inflammation of the tendon sheath or the presence of general active inflammation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SANKO University
Gaziantep, 27090
Halil Ibrahim ERGEN, 0905437202727, hiergen@sanko.edu.tr
About this study
Official title: Investigation of the Effect of Proprioceptive Sensory Training on Activity Limitation, Functional Use of Hand and Quality of Life in Individuals Undergoing Open Carpal Tunnel Relaxation
The aim of this study is to determine the benefits of sensory training for participants who are included in rehabilitation after carpal tunnel surgery.
- Conditions
- Proprioception
- Being tested
- Sensory Training, classical hand therapy
- Keywords
- sensory, carpal tunnel syndrome
- 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.
Sensory TrainingProcedure or surgery
The sensory training group includes sensory-oriented interventions and exercises unlike the other classical hand therapy group.
classical hand therapyOther
classical hand therapy
| Study group | Role | What they receive |
|---|---|---|
| Hand Therapy Group | Active comparator | Not described Receives: Other: classical hand therapy |
| Sensory Training Group | Experimental | Not described Receives: Procedure: Sensory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Position Matching
In our study, the wrist joint's range of motion will be evaluated in 2 different directions (flexion / extension and radial / ulnar deviation) for proprioception evaluation. For evaluations of all directions, the individual will be required to bring the wrist to the end of the movement, then to perform half the normal range of motion, while the wrist is in a hanging position from the table edge to allow full movement. The difference between the angular value and the angular value created by the individual will be noted by looking at the angular value on the fixed goniometer.
Measured: Baseline (First day)
Purdue Pegboard Test
The Purdue Pegboard Test is a neuropsychological test of manual dexterity and bimanual coordination.
Measured: Baseline (First day)
Activity Limitation
The Patient-Specific Functional Scale is a self-reported, patient-specific outcome measure, designed to assess functional change, primarily in patients presenting with musculoskeletal disorders. The scale was developed by Stratford et al 1995 as a self-report measure of function that could be used in patients with varying levels of independence. It was designed to provide clinicians with a valid, reliable, responsive, and efficient outcome measure that would be easy to use and applicable to a large number of clinical presentations.
Measured: Baseline (First day)
Health-Related Quality of Life
The EuroQoL-five-dimension (EQ-5D) is one of the most commonly used questionnaires to elicit health state utilities, having both a youth and an adult version. For general populations of adults two versions of the questionnaire have been developed, 3L and 5L, with the latter offering a more detailed description of health status. In order to use the EQ-5D to estimate quality-adjusted life-years, a value set to reflect people's preferences for different health states is needed.
Measured: Baseline (First day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start27 Jul 2018
- Primary completion15 Mar 2020 (estimated)
- Study completion15 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProprioceptionStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187677
- Sponsor's protocol ID
- Study-1
- Other IDs
- Halil Ibrahim Ergen
- Status last verified
- Dec 2019
- First submitted
- 21 Oct 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ergen HI, Keskinbicki MV, Oksuz C. The Effect of Proprioceptive Training on Hand Function and Activity Limitation After Open Carpal Tunnel Release Surgery: A Randomized Controlled Study. Arch Phys Med Rehabil. 2024 Apr;105(4):664-672. doi: 10.1016/j.apmr.2023.12.004. Epub 2023 Dec 21.
PubMed 38142026
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Proprioceptive Sensory Training on Activity Limitation, Functional Use of Hand and Quality of Life in Individuals Undergoing Open Carpal Tunnel Relaxation
- ClinicalTrials.gov ID
- NCT04187677
- Acronym / sponsor ID
- Study-1
- Conditions
- Proprioception
- Keywords
- sensory, carpal tunnel syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 27 Jul 2018 (actual)
- Primary completion
- 15 Mar 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 5 Dec 2019 (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.
The aim of this study is to determine the benefits of sensory training for participants who are included in rehabilitation after carpal tunnel surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Therapy Group | Active comparator | Other: classical hand therapy |
| Sensory Training Group | Experimental | Procedure: Sensory Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SANKO University Health Practice and Research Center, Orthopedics and Traumatology Unit underwent open carpal tunnel loosening surgery.
Key exclusion criteria (4 listed)
- The presence of nerve entrapment other than the median nerve (any sensory / motor deficits in the ulnar or radial nerve),
- Wrist injury history (fractures, carpal instabilities),
- Previous surgery in the hand or wrist region,
- Traumatic and recurrent Carpal Tunnel Syndrome, inflammation of the tendon sheath or the presence of general active inflammation
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 |
|---|---|---|
| Sensory TrainingThe sensory training group includes sensory-oriented interventions and exercises unlike the other classical hand therapy group. | Procedure or surgery | Sensory Training Group |
| classical hand therapyclassical hand therapy | Other | Hand Therapy Group |
Primary outcome
Joint Position Matching
Time frame: Baseline (First day)
In our study, the wrist joint's range of motion will be evaluated in 2 different directions (flexion / extension and radial / ulnar deviation) for proprioception evaluation. For evaluations of all directions, the individual will be required to bring the wrist to the end of the movement, then to perform half the normal range of motion, while the wrist is in a hanging position from the table edge to allow full movement. The difference between the angular value and the angular value created by the individual will be noted by looking at the angular value on the fixed goniometer.
Purdue Pegboard Test
Time frame: Baseline (First day)
The Purdue Pegboard Test is a neuropsychological test of manual dexterity and bimanual coordination.
Activity Limitation
Time frame: Baseline (First day)
The Patient-Specific Functional Scale is a self-reported, patient-specific outcome measure, designed to assess functional change, primarily in patients presenting with musculoskeletal disorders. The scale was developed by Stratford et al 1995 as a self-report measure of function that could be used in patients with varying levels of independence. It was designed to provide clinicians with a valid, reliable, responsive, and efficient outcome measure that would be easy to use and applicable to a large number of clinical presentations.
Health-Related Quality of Life
Time frame: Baseline (First day)
The EuroQoL-five-dimension (EQ-5D) is one of the most commonly used questionnaires to elicit health state utilities, having both a youth and an adult version. For general populations of adults two versions of the questionnaire have been developed, 3L and 5L, with the latter offering a more detailed description of health status. In order to use the EQ-5D to estimate quality-adjusted life-years, a value set to reflect people's preferences for different health states is needed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Derived from this study: PubMed 38142026Ergen HI, Keskinbicki MV, Oksuz C. The Effect of Proprioceptive Training on Hand Function and Activity Limitation After Open Carpal Tunnel Release Surgery: A Randomized Controlled Study. Arch Phys Med Rehabil. 2024 Apr;105(4):664-672. doi: 10.1016/j.apmr.2023.12.004. Epub 2023 Dec 21.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Training and classical hand therapy in people with Proprioception, run by Sanko University 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Halil Ibrahim ERGEN (0905437202727, hiergen@sanko.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint Position Matching (time frame: Baseline (First day)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187677, which also lists 1 linked publication.
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 5 Dec 2019.