- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187677
Effect of Sensory Training on Activity Limitation, Functional Use of Hand and Quality of Life After Wrist Surgery
December 4, 2019 updated by: Sanko University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Halil Ibrahim ERGEN
- Phone Number: 0905437202727
- Email: hiergen@sanko.edu.tr
Study Locations
-
-
-
Gaziantep, Turkey, 27090
- Recruiting
- SANKO University
-
Contact:
- Halil Ibrahim ERGEN
- Phone Number: 0905437202727
- Email: hiergen@sanko.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- SANKO University Health Practice and Research Center, Orthopedics and Traumatology Unit underwent open carpal tunnel loosening surgery.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hand Therapy Group
|
classical hand therapy
|
Experimental: Sensory Training Group
|
The sensory training group includes sensory-oriented interventions and exercises unlike the other classical hand therapy group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline (First day)
|
Purdue Pegboard Test
Time Frame: Baseline (First day)
|
The Purdue Pegboard Test is a neuropsychological test of manual dexterity and bimanual coordination.
|
Baseline (First day)
|
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.
|
Baseline (First day)
|
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.
|
Baseline (First day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 27, 2018
Primary Completion (Anticipated)
March 15, 2020
Study Completion (Anticipated)
May 15, 2020
Study Registration Dates
First Submitted
October 21, 2019
First Submitted That Met QC Criteria
December 4, 2019
First Posted (Actual)
December 5, 2019
Study Record Updates
Last Update Posted (Actual)
December 5, 2019
Last Update Submitted That Met QC Criteria
December 4, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Study-1
- Halil Ibrahim Ergen (Other Identifier: Sanko University)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Proprioception
-
Black Hills State UniversityCompletedProprioceptionUnited States
-
Inonu UniversityRecruiting
-
National Institutes of Health Clinical Center (CC)Completed
-
Foundation University IslamabadRecruitingProprioception, Postural BalancePakistan
-
Istanbul University - Cerrahpasa (IUC)Completed
-
Logan College of ChiropracticCompleted
-
Logan College of ChiropracticCompleted
-
Balgrist University HospitalRecruitingVibration; Exposure | Proprioception | Manipulation, PsychologicSwitzerland
-
Taibah UniversityCompletedProprioceptionSaudi Arabia
-
China Medical University HospitalEnrolling by invitationArthroplasty, Replacement, Knee | Gait | Proprioception | BalanceTaiwan
Clinical Trials on classical hand therapy
-
Dokuz Eylul UniversityCompletedPain | Hemodynamic Instability | Massage | Endotracheal Aspiration | ReflexologyTurkey
-
Izmir Katip Celebi UniversityCompletedAbsenteeism | Hand Hygiene | Respiratory Tract; Infection, Upper (Acute)Turkey
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Ahvaz Jundishapur University of Medical SciencesCompleted
-
Istanbul UniversityNot yet recruitingScleroderma, Systemic | Rehabilitation | Physiotherapy | Scleroderma | Hand Rheumatism | Scleroderma Associated Digital UlcerTurkey
-
University of Massachusetts, LowellUniversity of Massachusetts, WorcesterCompletedTrigger Finger | Trigger Digit | Stenosing Tenosynovitis
-
Istanbul UniversityCompletedScleroderma, Systemic | Rehabilitation | Physiotherapy | Scleroderma | Hand Rheumatism | Scleroderma Associated Digital UlcerTurkey
-
Odense University HospitalUniversity of Southern Denmark; Region of Southern Denmark; Bevica Fonden; Danish...CompletedHand Related InjuriesDenmark
-
Mayo ClinicCompleted