NCT03115879

Brief Summary

Introduction: Lower extremity weakness associated with musculoskeletal pathology can cause activity limitations. Physical therapy intervention in the form of exercise is commonly directed at improving muscular performance, however, neuromuscular adaptations may limit the effectiveness of traditional strengthening exercises. Manual therapy techniques have been used as a disinhibitory intervention to increase muscle activation and strength before participating in strengthening exercises or performing functional tasks While there is recent evidence to support joint mobilization as a valuable manual therapy disinhibitory intervention Currently, there is no evidence to substantiate anecdotal experience that a HVLAT hip distraction mobilization improves muscle performance in subjects with lower extremity pathology and lower extremity weakness. The purpose of this study was to determine if a HVLAT hip distraction mobilization would result in an immediate change of maximal force output of the quadriceps, gluteus maximus and gluteus medius. Methods: Forty individuals with a lower extremity pathology volunteered for this study. Inclusion criteria were having a unilateral musculoskeletal pathology, being greater than 18 years of age, 10% decrease in muscle strength in symptomatic side compared to healthy side, and absence of medical precautions that would prevent a maximal effort strength test and exclusion criteria included individuals with a history lower extremity recent muscle or tendon ruptures (within the past 6 months) and postoperative knee, hip and ankle surgery. Demographic data, including diagnosis from referring physician were collected. All subjects completed the Lower extremity function scale (LEFS). A single evaluator blinded to the involved extremity was responsible for quadriceps, gluteus medius and maximus strength analysis pre and post mobilization of both symptomatic and non-symptomatic sides. The subject underwent the HVLAT hip distraction mobilization of the symptomatic side, and an immediate re-assessment of strength of both symptomatic and non-symptomatic sides followed the mobilization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
Last Updated

April 14, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

March 23, 2017

Last Update Submit

April 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle strength

    A Lafayette dynamometer was used to evaluate the maximum isometric torque of the muscles

    Assessment of muscle strength was performed after 10 minutes of manipulation

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Hip manipulation simulation

Other: Hip manipulation simulation

Manipulation Group

EXPERIMENTAL

Hip manipulation

Other: Hip mobilization

Interventions

High velocity low amplitude hip mobilization of the experimental group

Manipulation Group

Hip manipulation simulation

Placebo Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals with a lower extremity pathology volunteered for this study
  • Being greater than 18 years of age
  • % decrease in muscle strength in symptomatic side compared to healthy side
  • Absence of medical precautions that would prevent a maximal effort strength test.

You may not qualify if:

  • Included individuals with a history lower extremity arthroplasty.
  • Recent muscle or tendon ruptures (within the past 6 months)
  • Unhealed fractures
  • Neurological diseases
  • Malignant cancer
  • Osteoporosis
  • Active infections processes
  • Early postoperative knee, hip and ankle surgery with range of motion and weight bearing restrictions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2017

First Posted

April 14, 2017

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

October 1, 2016

Last Updated

April 14, 2017

Record last verified: 2017-03