Tap Dance for Adults With Lower Limb Amputation | NCT06334146

Studies
Tap Dance for Adults With Lower Limb Amputation

NCT06334146

Sponsor

University of Nevada, Las Vegas

Status

Completed

Last Update Posted

Oct 15, 2024Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Amputation; Traumatic, Leg, Lower

Interventions

Tap dance program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 4, 2024Actual

Primary Completion Date

May 1, 2024Actual

Completion Date

May 1, 2024Actual

First Submitted Date

Feb 26, 2024

First Submission Date that Met QC Criteria

Mar 20, 2024

First Posted Date

Mar 27, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2024

Last Update Posted Date

Oct 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jenny Kent, Assistant Professor, University of Nevada, Las VegasPrincipal Investigator

Lead Sponsor

University of Nevada, Las VegasOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tap dance program	Experimental	Participants undertake tap dance program.	Other: Tap dance program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tap dance program	Other	Participants will take part in a weekly adapted tap dance class, for one hour per week, for eight weeks.	Tap dance program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in Timed Up-and-Go test score	Timed walking test in which the participant rises from a chair, walks to a marker 10 feet away, turns, and returns to sit in the chair. Time to complete, in seconds, is recorded.	8 weeks
Change in Four Square Step Test score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jenny A Kent, PhD	University of Nevada, Las Vegas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nevada Las Vegas		Las Vegas	Nevada	89154	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided