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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00432705
Other study ID # 05-11-34-CAI-B
Secondary ID
Status Completed
Phase Phase 1
First received February 6, 2007
Last updated July 21, 2009
Start date September 2006
Est. completion date September 2007

Study information

Verified date July 2009
Source University of North Carolina, Charlotte
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training. It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.


Description:

Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI). Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI. These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor measures through both short- and long-term reflex training. This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18-30, healthy

Exclusion Criteria:

- ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Checking stability of ankle
Flexing and walking

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Charlotte

Outcome

Type Measure Description Time frame Safety issue
Primary postural control 12 months No
See also
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Completed NCT02645097 - Ideal Anatomic Location for Saphenous Nerve Blocks: A Prospective Clinical Evaluation N/A
Completed NCT00954330 - Surgical Versus Functional Treatment for Acute Ruptures of the Lateral Ligament Complex of the Ankle in Young Males - A Randomized Controlled Trial With a Mean of 14 Years Follow-up N/A
Terminated NCT02643524 - Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use N/A