Joint Range of Motion

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by United States Army Institute of Surgical Research
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT01034813
First received: December 16, 2009
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the relationship between cutaneous functional unit(CFU)recruitment throughout the available active range of motion of a prescribed joint in normal subjects and patients with burn scars. Specifically, this study will determine if differences in CFU recruitment exist between normal subjects and individuals with burn scars at the dorsal hand, dorsal or volar forearm, or anterior or posterior arm during active range of motion of the MCP joint during flexion, or the wrist or elbow during flexion or extension, respectively.


Condition
Contractures Resulting From Burn Scar Tissue

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of Joint Range of Motion and Cutaneous Functional Unit Recruitment: Association With Burn Scar Characteristics

Resource links provided by NLM:


Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Range of motion [ Time Frame: 3-5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scar Hypertrophy [ Time Frame: 3--5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Burn Range of motion
burn patients with hypertropic scar
control range of motion
control subjects without scaring

Detailed Description:

Specific Aim #1: To establish the relationship between joint position and skin recruitment, expressed as the percentage of CFU recruited during active ROM, in patients with burn scars and normal controls.

Specific Aim #2: To establish the within-day and between-day reliability of percent CFU estimation and absolute skin recruitment, measured in millimeters from a fixed reference, during active ROM for a specified joint.

Specific Aim #3: To establish the relationship between scar height, measured by diagnostic ultrasound, scar cross-sectional area, and percent CFU recruitment in individuals with burn scar.

Specific Aim #4: To determine whether the amount of skin recruitment, expressed as the percent of the CFU recruited during active ROM, is differentially affected by burn scar.

Ho: There is no difference in the percent CFU recruited at the completion of active range of motion at a specified joint between individuals with burn scars and normal controls.

Ha: Individuals with burn scars recruit a greater percentage of the CFU in order to obtain maximal range of motion at a specified joint.

Specific Aim #5: To determine whether the timing of skin recruitment, expressed as the initiation of skin movement within a CFU relative to joint position during active ROM, is differentially affected by burn scar.

Ho: There is no difference in the initiation of skin movement within a CFU relative to joint position during active ROM at a specified joint between individuals with burn scars and normal controls.

Ha: In individuals with burn scars in a given CFU, skin movement farther from the joint axis occurs earlier in the range of motion compared to controls.

Specific Aim #6: To determine whether skin extensibility within a CFU during active ROM of a specified joint is differentially affected by burn scar.

Ho: There is no difference skin extensibility within a CFU during active ROM of a specified joint between individuals with burn scars and normal controls.

Ha: In individuals with burn scars in a given CFU, skin near the joint axis undergoes greater deformation (stretch) as range of motion at the joint increases compared to controls.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Military and civilian burn patients.Control population will be individuals without upper extremity injury.

Criteria

Inclusion Criteria:

  • Inclusion Criteria include: 1) male or female burn survivors between the ages of 18 and 60, 2) an area of scar covering at least fifty percent of the CFU of interest, 3) control subjects must have full active range of motion of the metacarpal phalangeal joints, wrist and elbow according to published normative references and be free of any history neuromusculoskeletal injury within the last three years that involved the joints of interest.

Exclusion Criteria:

  • Exclusion Criteria include: 1)burn survivors with an area of scar of less than fifty percent of the CFU of interest, 2) burn survivors with a history of orthopedic trauma to the upper extremity (i.e. sprain within the last 24 months, history of fracture, or history of joint dislocation), 3) control subjects with a history of upper extremity trauma or injury, 4) control subjects with the presence of scar tissue covering an area of more than one percent of the CFU of interest, 5) any potential subject with a history or rheumatoid arthritis, osteoarthritis affecting the extremity of interest, peripheral nerve injury of the extremity of interest, or systemic disorder affecting joint range of motion of the upper extremity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034813

Contacts
Contact: Mark Lester, DPT 210-916-1440 mark.lester@us.army.mil
Contact: Reginald Richard, PT 210-916-1440 reginald.richard@amedd.army.mil

Locations
United States, Texas
USAISR Recruiting
Fort Sam Houston, Texas, United States, 78234
Principal Investigator: Mark Lester, DPT         
Sponsors and Collaborators
United States Army Institute of Surgical Research
  More Information

Publications:
Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT01034813     History of Changes
Other Study ID Numbers: H-09-039
Study First Received: December 16, 2009
Last Updated: May 2, 2014
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
contractures, range of motion, scar formation

Additional relevant MeSH terms:
Burns
Contracture
Cicatrix
Wounds and Injuries
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014