NCT01787721

Brief Summary

The purpose of this study is to determine if manipulation of the ankle improves some measurable characteristics of how a person walks. The investigators hypothesize that the ankle will be able to bend better after manipulation and thus improve walking speed and reduce differences between the two limbs.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

1.8 years

First QC Date

November 5, 2012

Last Update Submit

December 22, 2014

Conditions

Gait

Keywords

GaitAnkle jointManipulation, Chiropractic

Outcome Measures

Primary Outcomes (1)

  • Change in self-selected walking speed

    Subjects will pick the speed they want to walk on the treadmill but will be blinded to their choice. The actual speed chosen will be recorded.

    Day 1 and 6 weeks

Secondary Outcomes (2)

  • Change in side-to-side difference in stance phase

    Day 1 and 6 weeks

  • Change in difference in step length from side-to-side

    Day 1 and 6 weeks

Study Arms (2)

Ankle manipulation

EXPERIMENTAL

Treatment will consist of manipulation of the tibiotalar joint intended to produce anterior to posterior glide of the tibia on the talus

Procedure: Ankle manipulation

Sham manipulation

SHAM COMPARATOR

Sham manipulative procedure of the tibiotalar joint.

Other: Sham manipulation

Interventions

Ankle manipulationPROCEDURE
Ankle manipulation
Sham manipulationOTHER
Sham manipulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Students will be screened for eligibility by testing their ability to perform a squat.

You may not qualify if:

  • a recent (within one month) ankle sprain
  • evidence of ankle instability
  • cardiac condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bridgeport College of Chiropractic Human Performance Laboratory

Bridgeport, Connecticut, 06604, United States

Location

Study Officials

  • Stephen M Perle, DC, MS

    University of Bridgeport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

February 11, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 23, 2014

Record last verified: 2014-12

Locations

US(1)