Effect of Nervous System Mobilization on Older Adults' Postural Control

March 25, 2019 updated by: Anabela G Silva, Aveiro University
This study aims to compare the effectiveness of nervous system mobilization and exercise with exercise only on institutionalized older adults' postural control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

It is anticipated that 26 institutionalized older adults will be randomly allocated to receive either exercise and neural mobilization (n=13) or exercise only (n=13).

Data on pain intensity (a vertical numeric rating scale) and location (body chart), depression (Geriatric Depression Scale), balance, hand grip strength, timed up and go and gait velocity will be collected at baseline, end of treatment and at 3 months follow up.

Statistical analysis will be performed using a mixed-methods ANOVA.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Portugal
      • Guarda, Portugal, 3810-193
        • Lar Santa Catarina do Reboleiro
      • Guarda, Portugal
        • Lar da Santa Cruz da Beselga

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • be 65 years of age or older;
  • to have independent gait with or without technical aid;
  • have indication of the institution's doctor for participation in the study

Exclusion Criteria:

  • inability to understand study aims.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise and nervous system mobilization
This group will receive neural mobilization and therapeutic exercise: two sessions of 60 minutes during 8 weeks.
Other: Exercise
The exercise program will consist of: 1) warm up - consisting of stretches of large muscle groups of the upper limbs, lower limbs and trunk and by general mobility exercises; 2) strength training of moderate intensity; 3) balance training; 4) Cooling - will consist of performing overall stretching combined with deep breathing.
Other: Neural mobilization
Neural gliding mobilization will target mainly the lower limb nerves and will be performed in series of 10 repetitions with 1 minute interval between series.
Experimental: Exercise
This group will receive therapeutic exercise: two sessions of 60 minutes during 8 weeks.
Other: Exercise
The exercise program will consist of: 1) warm up - consisting of stretches of large muscle groups of the upper limbs, lower limbs and trunk and by general mobility exercises; 2) strength training of moderate intensity; 3) balance training; 4) Cooling - will consist of performing overall stretching combined with deep breathing.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gait velocity
Time Frame: Baseline
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
Baseline
Gait velocity
Time Frame: 9 weeks
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
9 weeks
Gait velocity
Time Frame: 3 months
Participants are asked to walk at normal gait velocity over 4 meters and gait velocity is calculated
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Baseline
Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)
Baseline
Pain intensity
Time Frame: 9 weeks
Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)
9 weeks
Pain intensity
Time Frame: 3 months
Pain intensity measured using a vertical numeric rating scale (Range: 0 to 10 and higher values are indicative of higher pain intensity)
3 months
Pain location
Time Frame: Baseline
Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
Baseline
Pain location
Time Frame: 9 weeks
Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
9 weeks
Pain location
Time Frame: 3 months
Measured using a body chart (a graphic representation of the body) where participants identify painful body sites
3 months
Depressive symptoms
Time Frame: Baseline
Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
Baseline
Depressive symptoms
Time Frame: 9 weeks
Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
9 weeks
Depressive symptoms
Time Frame: 3 months
Measured using the 15-itens Geriatric Depression Scale (range: 0-15; participants who score 5 or more have depression)
3 months
Balance
Time Frame: Baseline
Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
Baseline
Balance
Time Frame: 9 weeks
Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
9 weeks
Balance
Time Frame: 3 months
Participants are asked to maintain a tandem/semi-tandem position for up to 30 seconds.
3 months
Timed up and go test
Time Frame: Baseline
Get up from a chair, walk 3 meters, go back to the chair and sit back. The amount of time that each participant takes to perform the task is taken.
Baseline
Timed up and go test
Time Frame: 9 weeks
Get up from a chair, walk 3 meters, go back to the chair and sit back.The amount of time that each participant takes to perform the task is taken.
9 weeks
Timed up and go test
Time Frame: 3 months
Get up from a chair, walk 3 meters, go back to the chair and sit back. The amount of time that each participant takes to perform the task is taken.
3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aveiro University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5/2018

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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