## Protocol Section
### Identification Module
**NCT ID:** NCT03115879

**Brief Title:** The Effect High Velocity Low Amplitude Hip Mobilization on Strength in Subjects With Lower Extremity Pathology

**Official Title:** The Effect of High Velocity Low Amplitude Hip Mobilization on Strength in Subjects With Lower Extremity Pathology

#### Organization Study ID Info
**ID:** DFreitas
#### Organization
**Class:** OTHER
**Full Name:** Faculdade de Ciências Médicas da Santa Casa de São Paulo
### Status Module
#### Completion Date
**Date:** 2016-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-14

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-03

**Type:** ACTUAL

#### Start Date
**Date:** 2015-02

**Type:** ACTUAL

**Status Verified Date:** 2017-03

#### Study First Post Date
**Date:** 2017-04-14
**Type:** ACTUAL
**Study First Submit Date:** 2017-03-23
**Study First Submit QC Date:** 2017-04-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Faculdade de Ciências Médicas da Santa Casa de São Paulo

#### Responsible Party

**Investigator Affiliation:** Faculdade de Ciências Médicas da Santa Casa de São Paulo

**Investigator Full Name:** Diego Galace de Freitas

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hip Joint

- Muscle Weakness

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Hip manipulation simulation

**Intervention Names:**

- Other: Hip manipulation simulation

**Label:** Placebo Group

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Hip manipulation

**Intervention Names:**

- Other: Hip mobilization

**Label:** Manipulation Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Manipulation Group

**Description:** High velocity low amplitude hip mobilization of the experimental group

**Name:** Hip mobilization

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Placebo Group

**Description:** Hip manipulation simulation

**Name:** Hip manipulation simulation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Muscle strength

**Time Frame:** Assessment of muscle strength was performed after 10 minutes of manipulation

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Individuals with a lower extremity pathology volunteered for this study
* Being greater than 18 years of age
* 10% decrease in muscle strength in symptomatic side compared to healthy side
* Absence of medical precautions that would prevent a maximal effort strength test.

Exclusion Criteria:

* 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.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000020879

- Term: Neuromuscular Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M20944

- Name: Muscle Weakness

- Relevance: HIGH

- As Found: Muscle Weakness

- ID: M13204

- Name: Paresis

- Relevance: LOW

- As Found: Unknown

- ID: M4554

- Name: Asthenia

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22619

- Name: Neuromuscular Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000018908

- Term: Muscle Weakness

### Misc Info Module

- Version Holder: 2024-05-24
