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Manual Therapy After Ankle/Hindfoot Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02609347
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
Stephanie Albin, Intermountain Health Care, Inc.

Brief Summary:
The aim of this randomized controlled trial is to assess if manual therapy improves mobility, gait, and balance more than a control group for patients who have undergone open reduction internal fixation (ORIF) after an ankle/hindfoot fracture.

Condition or disease Intervention/treatment Phase
Ankle Fracture Calcaneus Fracture Talus Fracture Pilon Fracture Other: Manual Therapy Group Other: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immediate Effects of Manual Therapy for Patients After Ankle/Hindfoot Fractures
Study Start Date : November 2015
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Manual Therapy Group
Participants in the manual therapy group will receive 3 treatment sessions of joint mobilization based on the physical therapist's clinical decision making.
Other: Manual Therapy Group
The manual therapy intervention will be based on the typed of fracture the patient sustained, and their limitations in joint mobility.

Sham Comparator: Control Group
Participants in the control group will receive a sham manual therapy treatment consisting of soft tissue mobilization and Grade I mobilizations at the proximal tib/fib joint.
Other: Control Group
The sham intervention will consist of soft tissue mobilization and Grade I mobilization at the proximal tib/fib joint.




Primary Outcome Measures :
  1. Range of motion (ROM) [ Time Frame: 2 weeks ]
    The dependent variable for Aim1 is weight bearing dorsiflexion ROM. The independent variables for Aim1 are treatment group (Manual therapy group versus Control group) and time

  2. Spatial and temporal gait parameters - gait velocity [ Time Frame: 2 weeks ]
    The dependent variable for Aim 2 is gait velocity. The independent variables for Aim 2 are treatment group (Manual therapy group versus Control group) and time.

  3. Balance [ Time Frame: 2 weeks ]
    The dependent variables for Aim3 is distances reached on the star excursion balance test. The independent variables for Aim3 are treatment group (Manual therapy group versus Control group) and time.


Secondary Outcome Measures :
  1. Characteristics that predict outcomes [ Time Frame: 2 weeks ]
    Multiple linear regression analysis will be performed to determine if baseline characteristics such as fracture type, age, etc can predict changes in biomechanical outcomes

  2. Foot Mobility - Foot Assessment Platform (FAP) [ Time Frame: 2 weeks ]
    The dependent variable is foot mobility. The independent variables are treatment group (Manual therapy group versus Control group) and time. Foot mobility will be assessed using the FAP.

  3. Muscle Stiffness - MyotonPRO Device [ Time Frame: 2 weeks ]
    The dependent variable is muscle stiffness. The independent variables are group and time. Muscles stiffness will be assessed using the MyotonPRO device.

  4. Stance Time [ Time Frame: 2 weeks ]
    The dependent variable is stance time. The independent variables are group and time.

  5. Single Limb Stance Time [ Time Frame: 2 weeks ]
    The dependent variable is single limb stance time. The independent variables are treatment group (Manual therapy group versus Control group) and time.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70 years
  2. Stiffness > 5.0 cm side to side difference as measured by the ankle lunge test
  3. Surgical management of ankle or hindfoot fracture
  4. Full weight-bearing (WB)
  5. Able to read and speak sufficient English to complete outcome tools

Exclusion Criteria:

  1. Any prior foot/ankle surgery, deformity, or injury on the unaffected side which would affect gait, WB dorsiflexion or balance
  2. Unable to attend follow-up visits
  3. Any cognitive impairments which would prevents patients from being able to complete or understand questionnaires
  4. Have received any previous manual therapy for their current ankle and/or hindfoot fracture
  5. Have a known non/malunion
  6. Have additional fractures of the spine, hip, or knee that would likely affect their weight bearing or gait
  7. Have avascular necrosis as demonstrated on radiographs
  8. Syndesmotic screw intact
  9. Open reduction internal fixation >12 months previously

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02609347


Locations
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United States, Utah
Intermountain Healthcare
Salt Lake City, Utah, United States, 84118
Sponsors and Collaborators
Intermountain Health Care, Inc.
University of Utah
Investigators
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Principal Investigator: Stephanie R Albin, DPT, FAAOMPT Intermountain Health Care

Publications of Results:

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Responsible Party: Stephanie Albin, DPT, OCS, FAAOMPT, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02609347    
Other Study ID Numbers: 1050061
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planning on sharing data
Keywords provided by Stephanie Albin, Intermountain Health Care, Inc.:
Manual Therapy
Ankle Fracture
Hindfoot Fracture
Additional relevant MeSH terms:
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Fractures, Bone
Ankle Fractures
Wounds and Injuries