Age-independent Decline in Manual Dexterity of Middle-aged and Older Adults

November 12, 2021 updated by: Roger Enoka, University of Colorado, Boulder
The objective of the clinical trial is to evaluate the mediating influence of force control on the pegboard times of adults (50-89 years) who are stratified into groups of faster and slower pegboard times. The hypothesis is that practice of either a pegboard test or a force-control task will reduce pegboard times, but the decrease will be greater and less similar after the two practice interventions for the slower group of participants. The outcomes are expected to demonstrate that force control is a modifiable mediator of pegboard times for this cohort, but the effect will be stronger for the group with faster pegboard times.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

The study will involve a randomized, cross-over design with a one-week washout between arms. The two arms (3 weeks each) will comprise practice of the grooved pegboard test and practice of steady contractions while lifting and lowering light loads with a hand muscle. Randomization into practice order will be accomplished with a block approach (block size = 4) for each of the two groups. The outcome assessors will be blinded to practice order. The outcomes will comprise three tests of manual dexterity and the measurement of force control during submaximal contractions. The outcomes will be obtained before and after the six sessions in each practice arm.

Study Type

Interventional

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 Locations

    • Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado Boulder

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

50 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to read, write, and speak English
  • Able to arrange transportation to the Boulder campus

Exclusion Criteria:

  • Cognitive impairment
  • Major psychiatric condition
  • Unstable depressive disorder
  • Progressive neurological, muscular, cardiovascular, or skeletal disorder
  • Chronic pain condition
  • Currently taking medication known to influence neuromuscular function
  • Recent hospitalization
  • Unable to attend 12 practice sessions in 6 weeks

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Faster
This group will comprise participants who complete the grooved pegboard test at baseline with a time of less than 71 seconds. One half of the members in this group will perform the two interventions in the order of pegboard practice and then force control practice, whereas the other half of the group will perform the two practice interventions in the opposite order.
Practice of the grooved pegboard test
Practice performing steady muscle contractions
Experimental: Slower
This group will comprise participants who complete the grooved pegboard test at baseline with a time of greater than 70 seconds. One half of the members in this group will perform the two interventions in the order of pegboard practice and then force control practice, whereas the other half of the group will perform the two practice interventions in the opposite order.
Practice of the grooved pegboard test
Practice performing steady muscle contractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grooved pegboard test
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
Time to complete the test as quickly as possible
Changes from baseline (week 1) at weeks 4 and 7
9-hole pegboard test
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
Time to complete the test as quickly as possible
Changes from baseline (week 1) at weeks 4 and 7
Jebsen Hand Function test
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
Time to complete the test as quickly as possible
Changes from baseline (week 1) at weeks 4 and 7
Force control
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
The coefficient of variation for force when subjects exert a constant submaximal force
Changes from baseline (week 1) at weeks 4 and 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EMG amplitude
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
Absolute amplitude of the electromyographic (EMG) signal for the involved muscles during the steady contractions
Changes from baseline (week 1) at weeks 4 and 7
MVC force
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
The peak force exerted during a maximal isometric contractions
Changes from baseline (week 1) at weeks 4 and 7
1-RM load
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
The maximal weight that can be lifted once
Changes from baseline (week 1) at weeks 4 and 7
Index finger acceleration
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
The average standard deviation of index finger acceleration in the abduction-adduction plane when a light load is being lifted and lowered during the practice intervention
Changes from baseline (week 1) at weeks 4 and 7
Motor unit discharge rates
Time Frame: Changes from baseline (week 1) at weeks 4 and 7
The discharge times of action potentials by motor units during the steady submaximal contractions
Changes from baseline (week 1) at weeks 4 and 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Roger Enoka, PhD, University of Colorado, Boulder

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 (Anticipated)

August 1, 2025

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18-0269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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