Amputation; Traumatic, Leg, LowerNCT06334146
Tap Dance for Adults With Lower Limb Amputation
A study testing Tap dance program in people with Amputation; Traumatic, Leg, Lower, run by University of Nevada, Las Vegas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation; Traumatic, Leg, Lower
- What is being tested?
- Tap dance program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nevada Las Vegas
Las Vegas, Nevada, 89154
About this study
Official title: Feasibility and Acceptability of Tap Dance as a Therapeutic Intervention for Adults With Lower Limb Amputation
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.
Read more
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.
- Conditions
- Amputation; Traumatic, Leg, Lower
- Being tested
- Tap dance program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tap dance programOther
Participants will take part in a weekly adapted tap dance class, for one hour per week, for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tap dance program | Experimental | Participants undertake tap dance program. Receives: Other: Tap dance program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Adherence
Number of planned dance tap sessions attended
Measured: 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.
Measured: Intervention week 8
Secondary outcomes (10)
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.
Measured: 8 weeks
Change in Four Square Step Test score
Time taken in seconds to complete a stepping sequence between two canes placed in a cross shape.
Measured: 8 weeks
Change in Berg Balance Scale score
Score out of 23, for performance of 14 mobility-related tasks.
Measured: 8 weeks
Change in Activities-Specific Balance Confidence Scale score
16 item self response scale measuring balance confidence. Scored out of 100%
Measured: 8 weeks
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.
Measured: Intervention week 4
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
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
Use of assistive devices per session
Percentage of sessions for which assistive devices are used
Measured: through study completion, over 8 weeks
Session completion per session
Percentage of planned dance tap sessions completed
Measured: through study completion, over 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start4 Mar 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation; Traumatic, Leg, LowerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Kent, University of Nevada, Las Vegas
- Investigators
- Jenny A Kent, PhD, Principal investigator, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334146
- Sponsor's protocol ID
- UNLV-2023-62
- Status last verified
- Oct 2024
- First submitted
- 26 Feb 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Tap Dance as a Therapeutic Intervention for Adults With Lower Limb Amputation
- ClinicalTrials.gov ID
- NCT06334146
- Acronym / sponsor ID
- UNLV-2023-62
- Conditions
- Amputation; Traumatic, Leg, Lower
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tap dance program | Experimental | Other: Tap dance programParticipants undertake tap dance program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tap dance programParticipants will take part in a weekly adapted tap dance class, for one hour per week, for eight weeks. | Other | Tap dance program |
Primary outcome
Session Adherence
Time frame: through study completion, over 8 weeks
Number of planned dance tap sessions attended
Physical Activities Enjoyment Scale (PACES)
Time frame: Intervention week 8
Total score on 18-item self response scale measuring enjoyment of an activity, out of a maximum 126.
10 secondary outcomes
Change in Timed Up-and-Go test score
Time frame: 8 weeks
Change in Four Square Step Test score
Time frame: 8 weeks
Change in Berg Balance Scale score
Time frame: 8 weeks
Change in Activities-Specific Balance Confidence Scale score
Time frame: 8 weeks
Physical Activities Enjoyment Scale (PACES) score - Mid program
Time frame: Intervention week 4
Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) functional activity restriction subscale score
Time frame: 8 weeks
Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) social activity restriction subscale score
Time frame: 8 weeks
Change in Trinity Amputation and Prosthesis Experience Scale (TAPES) athletic activity restriction score
Time frame: 8 weeks
Use of assistive devices per session
Time frame: through study completion, over 8 weeks
Session completion per session
Time frame: through study completion, over 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenny A Kent, PhD principal investigator
University of Nevada, Las Vegas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tap dance program in people with Amputation; Traumatic, Leg, Lower, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session Adherence (time frame: through study completion, over 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.