Prosthetic Performance Enhancement Trial

Amputation Clinical Trial

— PROSPER  

Official title:

Prosthetic Performance Enhancement Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06419920
• Other study ID #: UNLV-2023-595
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: University of Nevada, Las Vegas
• Contact: Jenny A Kent, PhD, CSci
• Phone: 7028955949
• Email: jenny.kent[@]unlv.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.

Description:

Despite advances in the technology for artificial limbs (prostheses), falling and the fear of falling continue to be barriers to mobility for many lower limb prosthesis users after their initial rehabilitation. The loss of ability and confidence in pursuing everyday tasks negatively impacts quality of life, and ongoing physical and mental health. This study will test and improve a rehabilitation training intervention involving walking on uneven ground to improve walking skill and confidence in lower limb prosthesis users. Lower limb prosthesis users will be recruited. Participants will be allocated randomly to receive either intervention A: training on a flat surface, or intervention B: training on an uneven surface. Depending on their ability and confidence, participants will complete the walking practice either on a treadmill or on a mat with an identical surface pattern. The walking practice will take place three times per week for four weeks. As each participant improves their ability, training tasks will be made more difficult by limiting handrail use, by increasing walking speed, and, for intervention B, also by making the walking surface more uneven. The objectives of this pilot study are to evaluate adherence and refine the training protocols in preparation for a definitive trial that will inform rehabilitation practices.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• lower limb amputation at ankle (Symes) level and above
• age 18+ years
• fitted with a walking prosthesis and use it regularly for home and/or community ambulation
• good socket fit, assessed by a score of 8-10 on the socket fit comfort scale
• able to walk for three minutes at a time with or without an assistive device
• willing to travel to the University of Nevada Las Vegas, Maryland Campus, for all training and assessment sessions

Exclusion Criteria:

• leg/foot ulcer or other conditions that cause pain during weight-bearing
• poor skin integrity that could cause tissue breakdown by walking
• cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity
• unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.
• pregnancy

Related Conditions & MeSH terms

• Amputation
• Lower Limb Amputation Above Knee (Injury)
• Lower Limb Amputation at Ankle (Injury)
• Lower Limb Amputation Below Knee (Injury)
• Lower Limb Amputation Knee
• Wounds and Injuries

Intervention

Other:
• Flat terrain locomotor training
The training will be comprised of up to 12 sets of 2-min continuous walking on a level treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four weeks.
• Uneven terrain locomotor training
The training will be comprised of up to 12 sets of 2-min continuous walking on an uneven terrain treadmill or mat, interspersed with rest breaks of at least one minute. Training will be completed three times per week for four 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	Percentage of planned sessions attended, per participant.	Through study completion, over 4 weeks
Secondary	L-test time	Time to complete L-test, in s. Participant rises from a chair and guided by cones, walks 10m forward, turns 90 degrees, walks a further 10m, turns 180 degrees, then follows the same path back to the chair and sits. Result from a single test following one practice trial is recorded.	Pre-intervention, within 5 days post intervention
Secondary	Activities-specific Balance Confidence Scale summary score	16-item self report measure recording confidence in performing activities during daily life that require balance, on numerical ratings scale, recorded as a percentage (out of 100).	Pre-intervention, within 5 days post intervention
Secondary	Average daily activity	Mean number of steps per day over 7 days, collected using ankle worn activity monitor.	Pre-intervention, within 5 days post intervention
Secondary	Four Square Step Test time	Time to complete forwards, lateral and backwards stepping pattern, in s.	Pre-intervention, within 5 days post intervention
Secondary	Beam walking distance	Distance traveled along a narrow beam, in m. Participants traverse a 3.66 m narrow beam. The distance traveled until the participant places a foot on the ground is measured. The mean of the final three of five trials is recorded.	Pre-intervention, within 5 days post intervention
Secondary	Two-minute walk test distance	Walking distance traveled in two minutes, in m.	Pre-intervention, within 5 days post intervention
Secondary	Protocol acceptability	Likert scale questions and short answer questions to determine acceptability of protocol to participants, assessed qualitatively.	End of intervention week 4
Secondary	Recruitment feasibility - recruitment rate	Number of participants recruited within one year	From start of recruitment period, to 12 month time point.
Secondary	Recruitment feasibility - participating clinics	Number of clinics from which at least one participant is recruited.	Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
Secondary	Recruitment feasibility - sample characteristics	Sample characteristics of all participants enrolled in the study, regardless of completion.	Through study completion, from start of recruitment period, to end of recruitment period or 30 month time point, whichever is sooner.
Secondary	Activity data evaluation	Completeness and quality of activity monitor data, measured as number of days with valid (non-erroneous) monitoring data.	Throughout activity monitoring period, over 2 weeks
Secondary	Maximum relative variability of lateral trunk velocity during uneven terrain in comparison to overground walking	Medial-lateral trunk variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of peak per-step lateral trunk velocity during UT walking sessions relative to that of overground walking, in m/s.	Through study completion, over 4 weeks
Secondary	Contour depth at maximum relative variability	Terrain contour depth at which the maximum relative variability was recorded, in m.	Through study completion, over 4 weeks
Secondary	Maximum relative step width variability during uneven terrain in comparison to overground walking	Step width variability will be quantified during each bout of walking during each session. The maximum relative variability will be calculated as the difference in variability (standard deviation) of step width during UT walking sessions relative to that of overground walking, in m.	Through study completion, over 4 weeks