AzTrials
AzTrials

Fall AccidentNCT03651297

Simple Fall-Arrest Harness vs. Adjustable Harness

A study testing Balance training with Fall-Arrest harness and Balance training with Adjustable harness in people with Fall Accident and Fall Injury, run by Cleveland State University at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
Search all trials

Trial summary

Fall risk increases with age and the fear of falling can significantly impact activity, mobility and future fall risk. Exercise designed specifically to help balance is effective at improving balance and postural control for mobility, gait, and other daily activities. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Fall Accident, Fall Injury, Balancing Interference
What is being tested?
Balance training with Fall-Arrest harness and Balance training with Adjustable harness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
20 Nov 2018to 30 Jun 2023
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age
  • Completed Informed Consent
  • Self-reported risk or fear of falling

Who cannot join

  • Medical Condition - they are not eligible if they self-identify as having any musculoskeletal, neuromuscular, cardiopulmonary, or other conditions that would limit them from participation.
  • Allergic to adhesive tape

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland State University

    Cleveland, Ohio, 44115

Other trials in United States

About this study

Official title: Testing a Simple Fall-arrest Harness vs. an Actuated and Instrumented Harness in Balance Training

Fall risk increases with age and the fear of falling can significantly impact activity, mobility and future fall risk. Exercise designed specifically to help balance is effective at improving balance and postural control for mobility, gait, and other daily activities. The individual purposes of this research are to (1) effectively use a prototype of an instrumented and actuated harness and support system, (2) demonstrate that this system can be used as designed during induced falls (reactive) and in place gaming (proactive) balance training protocols with the ability to modulate parameters as designed, measurements of harness system are accurate, and resultant output of the system matches intended parameters, and (3) demonstrate that the use of this system can allow provision of and study of varied balance training protocols, including: the measurements of the system, feedback of the system to participants, and the impact of the support parameters of the harness system on the task execution, learning and transfer.

Two separate groups of 20 participants (40 total participants) will be studied. The first group will include 20 individuals between the ages of 18 to 40 years old with no history of falls or fear of falling. The first group will complete two sessions of harnessed video gaming balance training. The second group will include older adults over the age of 55 with self-reported falls or the fear of falling. The second group of older adults will complete two sessions of a reactive (slip) training protocol. For both groups, the first session participants will be randomly assigned to use either a standard fall-arrest harness or the new BWS harness system. At the second session, they will switch the harness used. The protocol will involve slips or gaming based balance training, initially of low intensity and then advanced by algorithm based on their response to the trial just prior. This will allow comparison of postural control, perturbation responses, motor learning, and confidence with the system between the two harness types.

Read the detailed description

Fall risk increases with age and the fear of falling can significantly impact activity, mobility and future fall risk. Exercise designed specifically to help balance is effective at improving balance and postural control for mobility, gait, and other daily activities. Balance training for fall prevention can be proactive or reactive. Proactive balance training is the practice of anticipatory and self-initiated movement. Reactive training, on the other hand, involves responses to unexpected movements that cause a loss of balance. Safety harness systems are used for reactive balance protocols to prevent actual falls. They may also be used in intense proactive protocols for more vulnerable, frail, or fearful participants. In therapeutic settings, harnesses for gait and mobility training are either body weight supporting (BWS) or fall-arresting.

The investigators have designed and built a harness system that allows better control of more of the support parameters than much more expensive, commercially available, and BWS systems. This harness system better controls aspects such as: limiting fall distance, modulation of how the support responds to descents, assist to return to stand, and recording of all body movements. This will allow the investigation of questions about the impact of harness systems on learning and performance of postural control and effective use of harnesses in balance training.

The investigators have done extensive work with the Xbox system using Kinect, having designed a protocol and progression of games and surfaces that provides high intensity proactive balance training using Kinect. The investigators also train reactive balance through the use of a custom made platform called the Slip Trainer (MASS Rehab, Dayton, OH), along with a fall arresting harness and load measuring device. This allows the administration of repeated slip perturbations of a consistent and known intensity safely and efficiently.

Questions that still need to be answered include: Will patients challenge themselves more or engage in more intense activities with a harness? Does the support provided by a harness impact or interfere with the motor learning of the balance tasks? Could balance task learning be more effective with some degree of support vs. just a fall-arresting "backup" as is theorized with treadmill gait training? If so, what types and parameters are most effective? Would this type of support allow more intense training to be extended to people who are less mobile, more vulnerable or frail or more fearful, those who would not be able to participate in effective balance training otherwise?

This study will answer initial questions about the effectiveness and acceptance of the harness system by older adults in a reactive and by younger adults in a proactive protocol, and will provide pilot data for larger, external grants to investigate the broader questions among a much larger group of people. The larger impact will be translating the technology and understanding its impact clinically, allowing much greater intensity and more effective balance training for at risk populations.

The investigators propose to build a harness system in which the support within a single plane can be finely controlled and measured. This harness will have the following capabilities: limit height/fall to a pre-set vertical limit with ability to modulate the fall arrest kinematics, dynamic partial body weight support - to remain constant with center of mass (COM) movements, modulate by pre-set thresholds how the support responds to descent, assist to return to stand - with preset thresholds and levels of assist, monitor/measure/record: vertical and horizontal components of body COM movements, and provide feedback to users re: the support of being provided or re: other parameters, potentially in various modes (haptic, visual, auditory).

The individual purposes of this research are to (1) effectively use a prototype of an instrumented and actuated harness and support system, (2) demonstrate that this system can be used as designed during induced falls (reactive) and in place gaming (proactive) balance training protocols with the ability to modulate parameters as designed, measurements of harness system are accurate, and resultant output of the system matches intended parameters, and (3) demonstrate that the use of this system can allow provision of and study of varied balance training protocols, including: the measurements of the system, feedback of the system to participants, and the impact of the support parameters of the harness system on the task execution, learning and transfer.

Two separate groups of 20 participants (40 total participants) will be studied. Participants will be recruited from students, faculty and staff, as well as community members known to the investigator following the procedure outlined below. The first group will include 20 individuals between the ages of 18 to 40 years old with no history of falls or fear of falling. The first group will complete two sessions of harnessed video gaming balance training. The second group will include older adults over the age of 55 with self-reported falls or the fear of falling. The second group of older adults will complete two sessions of a reactive (slip) training protocol. For both groups, the first session participants will be randomly assigned to use a standard fall-arrest harness or the new BWS harness system. BWS harness can be set to support a predetermined portion of the person's body weight and maintain that support throughout the session. At the second session, they will switch the harness used. The protocol will involve balance training, advanced by algorithm, based on the participant's response to the trial just prior. This will allow comparison of postural control, perturbation responses, motor learning, and confidence with the system between the two harness types.

Being tested
Balance training with Fall-Arrest harness, Balance training with Adjustable harness
Keywords
Harness Assist, Balance training, Types of harness assist, Fall-arrest harness, Adjustable harness

What participants receive

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

  • Balance training with Fall-Arrest harnessOther

    This study will analyze the subjects' responses to balance training protocols with two types of harness support. The protocol will involve balance training, initially of low intensity and then advanced by an algorithm based on subjects' responses to the prior repetition of balance activity. For this intervention, the subjects will be using a standard Fall-Arrest harness for safety throughout, but no other external support. This will allow comparison of postural control, slip responses, motor learning, reliance on the harness and confidence with the system between the two harness types.

  • Balance training with Adjustable harnessOther

    This study will analyze the subjects' responses to balance training protocols with two types of harness support. The protocol will involve balance training, initially of low intensity and then advanced by an algorithm based on subjects' responses to the prior repetition of balance activity. For this intervention, the subjects will be using a motorized harness in which the support provided is adjustable. This will allow comparison of postural control, slip responses, motor learning, reliance on the harness and confidence with the system between the two harness types.

Study groups in NCT03651297
Study groupRoleWhat they receive
Younger AdultsExperimentalFirst group will include 20 young adults with no history of falls or fear of falling. They will complete both interventions: Balance Training with Fall-Arrest Harness and Balance Training with Adjustable Harness.
Receives: Other: Balance training with Fall-Arrest harness; Other: Balance training with Adjustable harness
Older adultsExperimentalSecond group will include 20 older adults with a self-reported history of falls or fear of falling. They will complete both interventions: Balance Training with Fall-Arrest Harness and Balance Training with Adjustable Harness.
Receives: Other: Balance training with Fall-Arrest harness; Other: Balance training with Adjustable harness

What is being measured

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

  1. Change (improvement) in response to increasingly difficult perturbations, as measured by the Rate of Perceived Stability Score (RPS).

    The protocols are advanced by algorithm. The reactive algorithm sets initial slip distance and force by the individual's leg length, weight, and MiniBEST (balance evaluation systems test). The result of each slip (harness loading and recovery steps) dictates the next condition as set forth in the algorithm. The proactive algorithm is a hierarchy of game and balance surface difficulty: participants begin at the same level and progress based on their Rate of Perceived Stability (RPS) score for each condition. The RPS self-rates balance task difficulty from 1 to 10 (least to most challenging). Advancing through more steps/more quickly with one harness indicates greater efficacy of that harness in balance skill acquisition. Because balance ability and the learning curve for balance tasks are highly individual, the outcome of interest is individual improvement in response to increasingly difficult perturbations, rather than standardized measure of balance ability across subjects.

    Measured: 2 sessions of 60 - 90 minutes, more than 3 days but less than three weeks apart.

Timeline

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

  1. First posted29 Aug 2018
  2. Study start20 Nov 2018
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion30 Jun 2023 (estimated)

Why it stopped: Lab closed due to Covid 19

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
The first group will complete two sessions of harnessed video gaming balance training. The second group will include older adults over the age of 50 with self-reported falls or the fear of falling. The second group of older adults will complete two sessions of a reactive (slip) training protocol. For both groups, the first session participants will be assigned randomly to use a standard fall-arrest harness or the new BWS harness system. At the second session, they will switch the harness used.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03651297
Sponsor's protocol ID
IRB-FY2018-324
Status last verified
Jul 2021
First submitted
14 Aug 2018
Last updated
6 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Balance training with Fall-Arrest harness and Balance training with Adjustable harness in people with Fall Accident and Fall Injury, run by Cleveland State University at 1 site in United States.

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 3 inclusion and 2 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: paused, as of the sponsor's last update on 6 Aug 2021. 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 United States. 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?

Results are not available in the source record.

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 (improvement) in response to increasingly difficult perturbations, as measured by the Rate of Perceived Stability Score (RPS). (time frame: 2 sessions of 60 - 90 minutes, more than 3 days but less than three weeks apart.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Aug 2021.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in