NCT06708104

Brief Summary

The proposed study is a prospective experimental single-arm pre-post study aiming to assess the effectiveness and feasibility of an outdoor therapeutic horse carriage, i.e., the Equine Dynamic Balance (EDB), as a form of reactive balance training. First, the investigators will describe the mechanical parameters of perturbations generated by the EDB's standing platform, including displacement, velocity and acceleration. Second, the investigators will assess the effect of EDB training on balance. Independent healthy young adults who do not suffer from balance impairments willing to participate in the study will be tested before and after EDB training, that will be delivered by standing on a dynamic therapeutic horse carriage pulled by a horse, to explore whether there are differences in balance control and balance reactions as a result of a 2-week EDB intervention program.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 18, 2024

Last Update Submit

November 24, 2024

Conditions

Keywords

Reactive balancePerturbation trainingAnimal-assisted therapy

Outcome Measures

Primary Outcomes (5)

  • Reactive stepping response

    the total step path length is the sum of the total distance each foot travelled during perturbation until completing the recovery stepping response. It will be measured in centimeters.

    change from baseline assessment (pre-test) to end of training program at 2 weeks (post-test).

  • Reactive stepping response during a training session

    the total step path length is the sum of the total distance each foot travelled during a perturbation until completing the recovery stepping response. It will be measured in centimetres.

    during a training session, an average of 20 minutes.

  • The three-dimensional perturbation displacement

    The three-dimensional displacement, in three axes, of the dynamic platform in a balance perturbation. It will be measured in centimetres.

    during a training session, an average of 20 minutes.

  • The three-dimensional perturbation velocity

    The three-dimensional velocity, in three axes, of the dynamic platform in a balance perturbation. It will be measured in meter per second (meter/second).

    during a training session, an average of 20 minutes.

  • The three-dimensional perturbation acceleration

    The three-dimensional acceleration, in three axes, of the dynamic platform in a balance perturbation. It will be measured in meter/secound2.

    during a training session, an average of 20 minutes.

Secondary Outcomes (4)

  • reactive grasping response

    change from baseline assessment (pre-test) to end of training program at 2 weeks (post-test).

  • reactive grasping response during a training session

    during a training session, an average of 20 minutes.

  • total recovery time during a training session

    during a training session, an average of 20 minutes.

  • total recovery time

    : change from baseline assessment (pre-test) to end of training program at 2 weeks (post-test).

Other Outcomes (1)

  • satisfaction and subjective effects on balance in daily lives

    at post-test, end of the 2-week training program.

Study Arms (1)

Outdoor horse-assisted perturbation training

EXPERIMENTAL

Outdoor perturbation training during Equine Dynamic Balance

Device: Outdoor horse-assisted perturbation training

Interventions

This is balance training in which a special carriage, i.e. a dynamic standing platform, is pulled by a horse on the outside surface, providing the trainee with multi-directional 3D balance perturbations that depend on the topography of the training area (various slopes and surface types), the horse walking speed, and its ability to stop, accelerate, and turns.

Outdoor horse-assisted perturbation training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young participants
  • Adults aged 18-45 years
  • Measuring between150-190 cm in stature, with a mass of less than 100 kg
  • No neurological or vestibular or orthopedic mobility impairing conditions, and with no current musculoskeletal injury.

You may not qualify if:

  • blindness or serious vestibular impairments (Meniere's disease, dizziness)
  • an inability to ambulate independently
  • symptomatic severe cardiovascular disease
  • neurological disorders such as stroke, Parkinson's, or Multiple sclerosis
  • orthopedic acute disorders requiring total hip or knee replacement
  • severe rheumatoid arthritis; and/or (g) cancer (metastatic or under active treatment).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 27, 2024

Study Start

December 1, 2024

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share