NCT06334146

Brief Summary

The goal of this study is to determine whether it is possible for people with lower limb amputation (LLA) to perform adapted tap dance, whether an adapted tap dance program would be enjoyable, and whether it may improve balance and balance confidence. There is a lack of research investigating therapeutic interventions for people with lower limb amputation (LLA). Tap dance encourages balance and novel movements of the limbs, while providing auditory feedback from the feet that provide information about the foot's contact with the ground, which may help prosthesis users gain a better ability to understand where their prosthetic foot is in space. As with most forms of dance, tap is usually taught and practiced in a group setting, which encourages community involvement. It has been shown to be safer than many forms of dance due to low impact forces. It also, as a genre, can incorporate canes, chairs and partner work, providing the ability to modify steps/moves when required so that they remain practical, achievable and safe for people with mobility limitations, while still enabling participation. It therefore may be an accessible dance medium to help improve balance, balance confidence, and build community for people with LLA. Participants will be asked to:

  • come to 1 hour dance classes, once per week, for 8 weeks.
  • do mobility tests before and after the program
  • complete questionnaires before, during and after the program. The total time for participation is approximately 8-10 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

February 26, 2024

Last Update Submit

October 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Session Adherence

    Number of planned dance tap sessions attended

    through study completion, over 8 weeks

  • Physical Activities Enjoyment Scale (PACES)

    Total score on 18-item self response scale measuring enjoyment of an activity, out of a maximum 126.

    Intervention week 8

Secondary Outcomes (10)

  • Change in Timed Up-and-Go test score

    8 weeks

  • Change in Four Square Step Test score

    8 weeks

  • Change in Berg Balance Scale score

    8 weeks

  • Change in Activities-Specific Balance Confidence Scale score

    8 weeks

  • Physical Activities Enjoyment Scale (PACES) score - Mid program

    Intervention week 4

  • +5 more secondary outcomes

Study Arms (1)

Tap dance program

EXPERIMENTAL

Participants undertake tap dance program.

Other: Tap dance program

Interventions

Participants will take part in a weekly adapted tap dance class, for one hour per week, for eight weeks.

Tap dance program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral or bilateral lower limb amputation at ankle level or above
  • fitted with a walking prosthesis, used regularly for walking in the home and the community
  • good socket fit
  • able to stand or walk for 2 minutes at a time with or without an assistive device
  • willing to travel to the University of Nevada Las Vegas for tap classes once a week for 8 weeks, and for two testing sessions
  • able to complete all required outcome measures
  • able to understand written and spoken English

You may not qualify if:

  • leg/foot ulcer/sore or other conditions that cause pain during weight-bearing
  • cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Study Officials

  • Jenny A Kent, PhD

    University of Nevada, Las Vegas

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 27, 2024

Study Start

March 4, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations