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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06334146
Other study ID # UNLV-2023-62
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2024
Est. completion date May 2025

Study information

Verified date March 2024
Source University of Nevada, Las Vegas
Contact Jenny A Kent, PhD
Phone 7028955949
Email Jenny.kent@unlv.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Nevada Las Vegas Las Vegas Nevada

Sponsors (1)

Lead Sponsor Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Session Adherence Number of planned dance tap sessions attended through study completion, over 8 weeks
Primary 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 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
Secondary Change in Four Square Step Test score Time taken in seconds to complete a stepping sequence between two canes placed in a cross shape. 8 weeks
Secondary Change in Berg Balance Scale score Score out of 23, for performance of 14 mobility-related tasks. 8 weeks
Secondary Change in Activities-Specific Balance Confidence Scale score 16 item self response scale measuring balance confidence. Scored out of 100% 8 weeks
Secondary Physical Activities Enjoyment Scale (PACES) score - Mid program Total score on 18-item self response scale measuring enjoyment of an activity, out of a maximum 126. Intervention week 4
Secondary Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) functional activity restriction subscale score Total score on functional activity restriction subscale of the TAPES - self reported outcome measure, out of maximum 12 8 weeks
Secondary Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) social activity restriction subscale score Total score on social activity restriction subscale of the TAPES - self reported outcome measure, out of maximum 12 8 weeks
Secondary Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) athletic activity restriction score Total score on athletic activity restriction subscale of the TAPES - self reported outcome measure, out of maximum 12 8 weeks
Secondary Use of assistive devices per session Percentage of sessions for which assistive devices are used through study completion, over 8 weeks
Secondary Session completion per session Percentage of planned dance tap sessions completed through study completion, over 8 weeks
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