NCT05593952

Brief Summary

The aim of this study will be to evaluate the effect of the dual task on hand motor performance, pain, functionality and psychosocial factors in patients with carpal tunnel syndrome undergoing surgery. Men and women aged 20-60 years with a medical diagnosis of CTS according to international clinical guidelines will be candidates for the present study. Patients receiving rehabilitation following carpal tunnel release surgery will be potentially eligible. After the familiarization week and the analysis of acute effects, subjects will be randomly distributed into two groups: 1) exercise with dual task + usual treatment; 2) exercise without dual task + usual treatment. The exercises performed will be the same as during the familiarization week, as well as the guidelines for performing them. Both groups will perform 4 weeks of intervention, for two days a week with two days of rest between sessions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

November 2, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

October 18, 2022

Last Update Submit

March 24, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscular endurance assessed by the maximum number of possible repetitions of exercise with elastic resistance

    The maximum number of possible repetitions of exercise with elastic resistance in each of the conditions shall be counted (to a perceived effort of BORG 3/10)

    Baseline (0 weeks)

  • Muscular endurance assessed by the maximum number of possible repetitions of exercise with elastic resistance

    The maximum number of possible repetitions of exercise with elastic resistance in each of the conditions shall be counted (to a perceived effort of BORG 3/10)

    Change from Baseline at 4 weeks

Secondary Outcomes (12)

  • Kinesiophobia assessed by the TSK-11

    Baseline (0 weeks)

  • Catastrophizing assessed by thePCS

    Baseline (0 weeks)

  • Self-efficacy assessed by the Perceived Chronic Pain Self-Efficacy questionnaire

    Baseline (0 weeks)

  • Severity of symptoms and function assessed by the BCTS

    Baseline (0 weeks)

  • Pain assessed by the VAS

    Baseline (0 weeks)

  • +7 more secondary outcomes

Study Arms (2)

Dual task

EXPERIMENTAL

The dual task will be self-regulated and will consist of subtracting 3 by 3 from 100, and performing the maximum number of repetitions possible. exercise with dual task + usual treatment;

Other: Dual task

Single task

ACTIVE COMPARATOR

exercise without dual task + usual treatment.

Other: Single task

Interventions

exercise with dual task + usual treatment

Also known as: Experimental
Dual task

exercise without dual task + usual treatment.

Also known as: Active comparator
Single task

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Medical diagnosis of CTS according to international clinical guidelines
  • Patients referred for rehabilitation after carpal tunnel release surgery
  • Agree to participate

You may not qualify if:

  • Inability to understand instructions.
  • Uncontrolled mental health pathology.
  • Cognitive problems.
  • Previous surgery on the upper extremity.
  • Complex regional pain syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

potassium channel subfamily K member 3

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Officials

  • Laura López-Bueno, PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 26, 2022

Study Start

November 2, 2022

Primary Completion

February 23, 2024

Study Completion

February 23, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations