Simple Fall-Arrest Harness vs. Adjustable Harness

NCT03651297 | Suspended

• 1 other identifier: IRB-FY2018-324
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fall Accident; Fall Injury; Balancing Interference

Keywords

Harness Assist; Balance training; Types of harness assist; Fall-arrest harness; Adjustable harness

Outcome Measures

Primary Outcomes (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.

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

Study Arms (2)

Younger Adults

EXPERIMENTAL

First 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.

Other: Balance training with Fall-Arrest harness; Other: Balance training with Adjustable harness

Older adults

EXPERIMENTAL

Second 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.

Other: Balance training with Fall-Arrest harness; Other: Balance training with Adjustable harness

Interventions

Balance training with Fall-Arrest harness OTHER

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.

Older adults; Younger Adults

Balance training with Adjustable harness OTHER

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.

Older adults; Younger Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cleveland State University: lead

Study Sites (1)

Cleveland State University

Cleveland, Ohio, 44115, United States

Location

Study Officials

• Debbie Espy

  Cleveland State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 29, 2018
• Study Start: November 20, 2018
• Primary Completion: July 31, 2022
• Study Completion: June 30, 2023
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)