A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis

• Sponsor: Angela DeCandia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02921295
• Collaborator: College Park Industries (Other)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 7.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.

Condition or Disease	Intervention/Treatment	Phase
Amputation Stumps	Device: Sidekick Stubbies	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sidekick Stubbies Conventional Stubby prostheses were used for baseline measures. In the sequential crossover design, articulated stubby prostheses ("Sidekick" manufactured by College Park Ind.) were used as intervention	Device: Sidekick Stubbies

Outcome Measures

Primary Outcome Measures

1. Average Speed for 10 Meter Walk Test [2 times throughout study completion (every 1 hour during the 2 hour protocol)]

   The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.

Secondary Outcome Measures

1. Timed up and go Test Time [6 times throughout study completion (3 every 1 hour during the 2 hour protocol)]

   The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.

2. Gait Symmetry Index [2 times throughout study completion (every 1 hour during the 2 hour protocol)]

   Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• bilateral transfemoral amputee

• own a pair of conventional stubby prosthesis with standard adaptation

Exclusion Criteria:

• dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them)

• use of prosthesis that do not allow change of feet with standard adapters

• any medical condition that may put an individual in greater risk of injury than normal daily activity.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bakery Square MSPO labs	Pittsburgh	Pennsylvania	United States	15206

Sponsors and Collaborators

• Angela DeCandia
• College Park Industries

Investigators

None specified.

Study Documents (Full-Text)

• Statistical Analysis Plan - Sep 27, 2016
• Informed Consent Form - Sep 27, 2016
• Study Protocol - Sep 27, 2016

More Information

Publications

None provided.

• Responsible Party: Angela DeCandia, Prosthetic & Orthotic Resident, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02921295
• Other Study ID Numbers: PRO16050355
• First Posted: Oct 3, 2016
• Last Update Posted: Jun 21, 2018
• Last Verified: Apr 1, 2018

Study Results

Participant Flow

Arm/Group Title	Sequential Change of Intervention
Arm/Group Description	Conventional Stubby prostheses and Sidekicks prostheses were used in a randomized sequence
Period Title: Sidekicks
STARTED	1
COMPLETED	1
NOT COMPLETED	0
Period Title: Sidekicks
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sequential Change of Interventions
Arm/Group Description	Conventional Stubby prostheses will be used in this intervention
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41 (0)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	1 100%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

Title	Average Speed for 10 Meter Walk Test
Description	The participant is timed while covering a 10-m distance unassisted (running start). The average speed is then calculated for each pass (one with each set of prosthetic feet), using the equation 10m/(recorded time in seconds). The average speed is computed as it is more reliable and representative than the instantaneous gait speed that may not be consistently maintained during the 10-m walk.
Time Frame	2 times throughout study completion (every 1 hour during the 2 hour protocol)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stubbies	Sidekicks
Arm/Group Description	Conventional Stubby prostheses as control intervention in cross-over trial	Active intervention in cross-over trial
Measure Participants	1	1
Number [m/s]	0.57	0.53

2. Secondary Outcome

Title	Timed up and go Test Time
Description	The test, as described in the protocol form, is performed three times with each intervention. This allows averaging to reduce the risk of random errors in timing the exercise. Accordingly, the participant is asked to repeat (with resting breaks in between) the tests three times with the stubbies and three times with the sidekicks.
Time Frame	6 times throughout study completion (3 every 1 hour during the 2 hour protocol)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stubbies	Sidekicks
Arm/Group Description	control intervention	active intervention
Measure Participants	1	1
Mean (Standard Deviation) [s]	0.27 (0.0103)	0.25 (0.0074)

3. Secondary Outcome

Title	Gait Symmetry Index
Description	Left/Right Step Duration Ratio. Perfect gait symmetry would result in a ratio of 1.000. Any deviation would indicate that step lengths differ between legs, indicating a more or less pronounced limping. The measure is computed from the intermediary step sample of gait with each intervention. This allows averaging to reduce the risk of random errors in assessment. Step samples were extracted from walking trial data with the stubbies and with the sidekicks. Each walking trial contains more than 30 individual steps for analysis.
Time Frame	2 times throughout study completion (every 1 hour during the 2 hour protocol)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stubbies	Sidekicks
Arm/Group Description	Control intervention	active intervention
Measure Participants	1	1
Mean (Standard Deviation) [ratio]	1.046 (0.119)	0.965 (0.113)

Adverse Events

Time Frame	1 day
Arm/Group Title	Stubbies		Sidekicks
Arm/Group Description	Control intervention		active intervention
All Cause Mortality
	Stubbies		Sidekicks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Serious Adverse Events
	Stubbies		Sidekicks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Stubbies		Sidekicks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.