NCT04187677

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

1.6 years

First QC Date

October 21, 2019

Last Update Submit

December 4, 2019

Conditions

Proprioception

Keywords

sensorycarpal tunnel syndrome

Outcome Measures

Primary Outcomes (4)

  • 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.

    Baseline (First day)

  • Purdue Pegboard Test

    The Purdue Pegboard Test is a neuropsychological test of manual dexterity and bimanual coordination.

    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.

    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.

    Baseline (First day)

Study Arms (2)

Hand Therapy Group

ACTIVE COMPARATOR
Other: classical hand therapy

Sensory Training Group

EXPERIMENTAL
Procedure: Sensory Training

Interventions

Sensory TrainingPROCEDURE

The sensory training group includes sensory-oriented interventions and exercises unlike the other classical hand therapy group.

Sensory Training Group
classical hand therapyOTHER

classical hand therapy

Hand Therapy Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SANKO University Health Practice and Research Center, Orthopedics and Traumatology Unit underwent open carpal tunnel loosening surgery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SANKO University

Gaziantep, 27090, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38142026DERIVED

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

Central Study Contacts

Halil Ibrahim ERGEN

CONTACT

0905437202727hiergen@sanko.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

December 5, 2019

Study Start

July 27, 2018

Primary Completion

March 15, 2020

Study Completion

May 15, 2020

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

TU(1)