AlterG ACL Return to Running Case Series

NCT02335645 | Completed

• 1 other identifier: IRB14-00823
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This case series will follow standard ACL protocol, while using biomechanical movement analysis to analyze running mechanics using a body weight supported treadmill. Standard ACL protocol will be followed throughout the treatment of each patient. The only variance from treatment will be using motion analysis software to analyze gait patterns at different points throughout the rehabilitation. The first motion analysis will be performed at week 6 of the rehabilitation process. Prior to this treatment, manual muscle testing of the hip, knee and ankle using a handheld dynamometer, two outcome measures, range of motion, pain, and patient satisfaction will be performed. At this treatment, motion capture sensors will be placed on the patient at different anatomical positions. The patient will then run in a body weight supported treadmill. During this run, video capture will be performed and later analyzed to determine biomechanical kinematics. This process will be repeated at week 8 of rehabilitation in the body weight supported treadmill. At week 10, the patient will shift treatment from the body weight supported treadmill, to a standard treadmill. The process will be repeated using the same anatomical landmarks and video capture. The final video capture will be performed at week 12. At this visit, video capture will be performed. The patient will also repeat all test, measures, and questionnaires from week 6. At all visits between video capturing, standard PT will be performed with a focus on patient deficits and following the standard protocol.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

ACL reconstruction; Running Mechanics; Physical Therapy; Knee; Video Analysis; Body Weight Supported Treadmill

Outcome Measures

Primary Outcomes (4)

• Change in Pedi-IKDC

  Pediatric International Knee Document Committee (Pedi-IKDC) is a self-reported questionnaire relating to a young patients function, symptoms, and sports activity. This is a valid study in patients ages 10-18

  Measure week 6 and week 12 following surgery

• Change in KOOS

  Knee injury and Osteoarthritis Outcome Score (KOOS) is a patient reported outcome measure intended for use in knee injuries that may result in osteoarthritis such as anterior cruciate reconstruction. This measure is valid in individual's age 13-79 years and consists of 5 subscales

  Measure week 6 and week 12 following surgery

• Change in numeric pain rating scale

  The use of the Numerical Pain Rating Scale (NPRS) for assessing pain has been validated for use in adolescent patients and has been found to have a minimal detectable change of 2 points. The NPRS will be administered at the beginning and end of every treatment session

  Measure week 6 and week 12 following surgery

• Change in manual muscle testing

  Manual Muscle Testing (MMT) will be administered using a hand held dynamometer. This will be performed for hip flexion, extension, abduction and adduction. MMT will also be performed for knee flexion and extension, as well ankle plantar flexion, dorsiflexion, inversion, and eversion.

  Measure week 6 and week 12 following surgery

Secondary Outcomes (7)

• Change in dynamic knee valgus

  Measured week 6 and week 12 following surgery

• Change in dynamic knee flexion

  Measured week 6,8,10,12 following surgery

• Change in ankle dorsiflexion/plantar flexion

  Measured week 6,8,10, and 12 following surgery

• Change in vertical excursion

  measured week 6,8,10,12 following surgery

• change in hip drop

  measured week 6,8,10,12 following surgery

Study Arms (1)

Body Weight Supported Treadmill

Post surgical ACL patients who will complete standard ACL protocol with the addition of body weight supported treadmill use.

Other: Body Weight Supported Treadmill Use of Patients with ACL Reconstruction

Interventions

Body Weight Supported Treadmill Use of Patients with ACL Reconstruction OTHER

Standard ACL protocol will be followed throughout the treatment of each patient. The only variance from treatment will be using body weight supported treadmill and video gait analysis to help guide treatment. The first analysis will be performed at week 6 after surgery. Motion capture sensors will be placed on the patient at different anatomical positions. The patient will then run in a body weight supported treadmill. During this run, video capture will be performed and later analyzed to determine biomechanical kinematics. Based on findings of video gait analysis, exercise progression will be altered to improve deficits found. This process will be repeated at week 8 of rehabilitation in the body weight supported treadmill. At week 10 and 12, the patient will shift treatment from the body weight supported treadmill, to a standard treadmill. The process will be repeated using the same anatomical landmarks and video capture.

Body Weight Supported Treadmill

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will include post operative ACL patients who meet the eligibility criteria who are being treated at Nationwide Children's Westerville Physical Therapy location.

You may qualify if:

• Patients with a diagnosis of post operative anterior cruciate reconstruction surgery.

You may not qualify if:

• Patient has concurrent diagnosis of meniscal repair with ACL surgery.
• Patient ACL surgery is apophyseal sparing.
• Patient is unable to follow directions
• History of activity limiting illness
• Inability to attend follow up appointments
• Current Pregnancy

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital Sports and Ortho PT Westerville

Westerville, Ohio, 43082, United States

Location

Study Officials

• Mitchell Selhorst, DPT

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 12, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

US (1)