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AgingNCT04920201

The Effect of Exercise With Wearable Walking Assist Robot in Various Environments

A study testing Over-ground walking without GEMS-H, Over-ground walking with GEMS-H with resist mode and Stair ascent with GEMS-H with assist mode in people with Aging, run by Samsung Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single-blinded, randomized, controlled trial includes 60 healthy adults. The participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H applied resistance mode, the third group performed stair… Read more about this study

Who is it for?
Ages 65 to 84 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Over-ground walking without GEMS-H, Over-ground walking with GEMS-H with resist mode and Stair ascent with GEMS-H with assist mode
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
7 Jun 2021to 30 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 84 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Healthy adults aged 50 to less than 85 years without a history of central nervous system disease

Who cannot join

  • Those who have difficulty walking independently due to problems such as visual field defects or fractures
  • Those with severe arthritis or orthopedic problems limiting passive range of motion (ROM) of the lower extremities (knee flexion contracture >10°, knee flexion ROM <90°, hip flexion contracture >25°, ankle plantar flexion contracture >15°)
  • Those who have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
  • Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
  • Those who are at risk of falling while walking due to severe dizziness
  • Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
  • Those who are overweight based on body mass index (BMI) 35 or higher

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: The Effect of Exercise With Wearable Walking Assist Robot in Various Environments in Healthy Adults

This single-blinded, randomized, controlled trial includes 60 healthy adults. The participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H applied resistance mode, the third group performed stair ascent with GEMS-H applied assist mode, and the fourth group were designated as the group that performed inclined gait with GEMS-H applied assist mode on a treadmill. Each group is divided in 15 participants.

Read the detailed description

At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. If the subjects meet the selection criteria, the participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H with resistance mode, the third group performed stair ascent with GEMS-H with assist mode, and the fourth group were designated as the group that performed inclined gait with GEMS-H with assist mode on a treadmill. Each group is divided in 15 participants. Each group completed 30 minutes exercise at least three times per week (total 10 sessions). All measurements were conducted before and after the intervention.

Conditions
Aging
Being tested
Over-ground walking without GEMS-H, Over-ground walking with GEMS-H with resist mode, Stair ascent with GEMS-H with assist mode, Incline walking with GEMS-H with assist mode
Keywords
wearable hip assist robot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Over-ground walking without GEMS-HOther

    Over-ground walking without GEMS-H (30 min per session, at least 3 times per weeks, total 10 sessions)

  • Over-ground walking with GEMS-H with resist modeDevice

    Over-ground walking with GEMS-H with resist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

  • Stair ascent with GEMS-H with assist modeDevice

    Stair ascent with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

  • Incline walking with GEMS-H with assist modeDevice

    Incline walking with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

Study groups in NCT04920201
Study groupRoleWhat they receive
Over-ground walking without GEMS-HExperimentalNot described
Receives: Other: Over-ground walking without GEMS-H
Over-ground walking with GEMS-H with resist modeExperimentalNot described
Receives: Device: Over-ground walking with GEMS-H with resist mode
Stair ascent with GEMS-H with assist modeExperimentalNot described
Receives: Device: Stair ascent with GEMS-H with assist mode
Incline walking with GEMS-H with assist modeExperimentalNot described
Receives: Device: Incline walking with GEMS-H with assist mode

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline performance on gait speed after the intervention

    Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."

    Measured: Baseline, After the intervention(day12)

Secondary outcomes (10)

  1. Change from baseline performance on muscle strength after the intervention

    All subjects underwent measurements of muscle strength of lower extremity by using Commander Echo Muscle Tester (measures in lb, kg, N)

    Measured: Baseline, After the intervention(day12)

  2. Change from baseline performance on Short Physical Performance Battery (SPPB) after the intervention

    The Short Physical Performance Battery (SPPB) is a series of tests used to evaluate lower extremity function and mobility.

    Measured: Baseline, After the intervention(day12)

  3. Change from baseline performance on Functional Reach Test (FRT) after the intervention

    Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.

    Measured: Baseline, After the intervention(day12)

  4. Change from baseline performance on Four Square Step Test (FSST) after the intervention

    Four Square Step Test (FSST) is a test of dynamic balance and coordination that clinically assesses the participant's ability to step over objects forward, sideways, and backwards.

    Measured: Baseline, After the intervention(day12)

  5. Change from baseline performance on Berg Balance Scale (BBS) after the intervention

    Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and fall risk in adults.

    Measured: Baseline, After the intervention(day12)

  6. Change from baseline performance on Timed Up and Go test (TUG) after the intervention

    The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

    Measured: Baseline, After the intervention(day12)

  7. Change from baseline performance on Geriatric Depression Scale (GDS) after the intervention

    The Geriatric Depression Scale (GDS) is a self-report measure of depression.

    Measured: Baseline, After the intervention(day12)

  8. Change from baseline performance on EuroQol 5 Dimensions (EQ-5D) after the intervention

    EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Measured: Baseline, After the intervention(day12)

  9. Change from baseline performance on Fall Efficacy Scale-Korea (FES-K) after the intervention

    The Falls Efficacy Scale (FES) is a ten-item test rated on a 10-point scale from not confident at all to completely confident.

    Measured: Baseline, After the intervention(day12)

  10. Change from baseline performance on metabolic energy expenditure after the intervention

    All subjects underwent measurements respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes. It assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (K5, Rome, Italy).

    Measured: Baseline, After the intervention(day12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start7 Jun 2021
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04920201
Sponsor's protocol ID
2021-03-052
Status last verified
Feb 2023
First submitted
1 Jun 2021
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Over-ground walking without GEMS-H, Over-ground walking with GEMS-H with resist mode and Stair ascent with GEMS-H with assist mode in people with Aging, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline performance on gait speed after the intervention (time frame: Baseline, After the intervention(day12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04920201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.

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