The Effect of Functional Task Training Combined With Therapeutic Ultrasound on Adults With Hip Osteoarthritis

September 9, 2021 updated by: ROSY PAOLA CARDENAS SANDOVAL, Universidad del Rosario

The Effect of a Functional Task-training Program Combined With Therapeutic Ultrasound on Pain, Strength, Gait Biomechanics and Functionality in Adults With Hip Osteoarthritis

The aim of this study is to evaluate the effect of a functional task-training program combined with therapeutic ultrasound on pain, strength, gait biomechanics and functionality in adults with hip osteoarthritis.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Design

The investigators propose a randomized double blind controlled clinical trial. It would include two comparison groups each with 25 participants with medical diagnosis of hip osteoarthritis classified severity II and III and inclusion criteria of the American College of Rheumatology for the classification and reporting of osteoarthritis of the hip.

All qualified participants will attend a pre-training (baseline) data collection session. During the data collection session, each participant will complete the Western Ontario and MacMaster Osteoarthritis Index (WOMAC). All participants will perform visual analog scale and six minutes walk test for assessing pain and functionality, respectively. They will be assessed their hip muscle strength using manual muscle dynamometer. Their biomechanics gait will be assessed through using an infrared motion capture system, force platforms and motion analysis software (120 Hz, BTS Smart DX100, Italy). All participants in both groups will be asked not to alter their regular physical activity or pain medications during the 15-sessions training program.

Each participant will be assessed pain, strength, gait biomechanics and functionality before and after 16 sessions of intervention. Pain and functionality will be further evaluated in sessions 5th and 10th. The first group will receive 16 sessions of a functional task training program and therapeutic ultrasound versus the second group who will only receive 16 sessions of the same functional task-training program.

Functional task-training program includes warm up, followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching. Therapeutic ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes. Temporal average intensity area corresponds to 0.44 W/cm2, the treatment area will be equal to 2 times the effective radiating area on the anterior, medial and lateral hip area.

The hypothesis of this study is the functional-task training program combined with therapeutic ultrasound will decrease the pain, improve the muscle hip strength the gait biomechanics and the functionality of the people with hip osteoarthritis.

In the statistical analysis of the results, the differences will be assessed in the three pain and functionality assessments with a repeated measures using ANOVA; the differences between initial and final measurement of strength, biomechanical gait variables and functionality will be evaluated with a paired Student t-test and Wilcoxon. The differences between groups will be assessed with a t-test for independent samples. Significant differences in the outcomes will be adjusted for covariates with binomial regressions, considering a significance level of p <0.05.

For patient registries:

The Mederi Hospital has an integrated system for collecting, storing, monitoring, reviewing, and reporting on registry data of the participants of the study. It also has a Manual documentation of procedures for each registry, includes protocols and data collection instrument. The manual explains how the investigators should create or assign the patient identification numbers and how duplicate records should be prevented and how to report adverse events.

The hospital takes plans for monitoring or auditing the screening practices trough the auditing department and training to educate data collectors.

Additionally, the investigators will make a Pilot Testing to assess understanding, acceptance and feasibility the patient registry processes.

In the other hand, all staffs involved in data collection will be identified, and their roles and job will be described in data collection and processing.

All data collection will be registered in the integrated system of the Mederi Hospital. The gait biomechanics data will be recorded first in the database of the Smart DX100 system of the Laboratory of Biomechanics if the University of Rosario. The investigators will have an external research (Fulbright Scholar) that will audit the register of the biomechanics data. Then, every participant of the study will have an electronic medical record (EMR) of health-related information.

The Mederi Hospital has a system security plan that includes the policies, standard operating procedures, administrative procedures, electronic signatures and it also has a technical security support.

The plan for missing data where variables are reported as missing,unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results the investigators will quantify the extent of missingness, identifying which individuals have missing data and at which assessment then, the investigators will treat the missing data across a statistical analysis.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, Colombia
        • Universidad del Rosario

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of hip osteoarthritis

Exclusion Criteria:

  • Musculoskeletal disability in other lower extremity joints or trunk
  • Acute injuries of lower extremity and trunk in past three months
  • Arthroscopic surgery
  • An intra-articular injection in past three months
  • Candidate for surgery
  • Patients with fibromyalgia
  • Patients with neurologic disease
  • Participation in a structured physical activity program in past three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional task-training and Ultrasound
This group will receive 16 sessions of functional task-training program and therapeutic ultrasound will be applied prior to functional task-training.
Other: Functional task-training
The functional task-training program includes warming up followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching.
Device: Therapeutic Ultrasound
Therapeutic pulsed ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes on the anterior, medial and lateral hip area.
Active Comparator: Functional task-training
This group will receive 16 sessions of functional task-training program.
Other: Functional task-training
The functional task-training program includes warming up followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale for pain
Time Frame: within the first 2 weeks before the intervention
To measure the pain intensity
within the first 2 weeks before the intervention
Change from Baseline Visual Analog Scale for pain at 16th session of intervention
Time Frame: within the first 2 weeks after the intervention
within the first 2 weeks after the intervention
Muscle strength
Time Frame: within the first 2 weeks before the intervention
It is the muscle strength of gluteus maximus, medium, quadriceps and hamstrings measured using a manual muscle dynamometer.
within the first 2 weeks before the intervention
Change from Baseline Muscle strength at 16th session of intervention
Time Frame: within the first 2 weeks after the intervention
Change of the muscle strength of gluteus maximus, medium, quadriceps and hamstrings after the intervention.
within the first 2 weeks after the intervention
Gait biomechanics
Time Frame: within the first 2 weeks before the intervention
Assess the speed, hip range of motion, and peak hip flexion/extension in the gait phases by using motion analysis system BTS SmartDX100 Brand.
within the first 2 weeks before the intervention
Change from Baseline Gait biomechanics at 16th session of intervention
Time Frame: within the first 2 weeks after the intervention
within the first 2 weeks after the intervention
Six minute walk test (To measure the physical function in terms of the basic mobility)
Time Frame: within the first 2 weeks before the intervention
within the first 2 weeks before the intervention
Change from Baseline Six minute walk test at 16th session of intervention
Time Frame: within the first 2 weeks after the intervention
within the first 2 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Visual Analog Scale for pain at 5th session of intervention
Time Frame: After finishing the 5th session of intervention
After finishing the 5th session of intervention
Change from Baseline Visual Analog Scale for pain at 10th session of intervention
Time Frame: After finishing the 10th session of intervention
After finishing the 10th session of intervention
Change from Baseline Six minute walk test at 5th session of intervention
Time Frame: After finishing the 5th session of intervention
After finishing the 5th session of intervention
Change from Baseline Six minute walk test at 10th session of intervention
Time Frame: After finishing the 10th session of intervention
After finishing the 10th session of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Rosario

Collaborators

CORPORACION HOSPITALARIA JUAN CIUDAD, MEDERI

Investigators

  • Study Director: Songning Zhang, PhD, Director, Biomechanics/Sports Medicine Lab, Department of Kinesiology, Recreation, & Sport Studies College of Education, Health and Human Sciences. The University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2017

Primary Completion (Actual)

January 8, 2018

Study Completion (Actual)

January 9, 2018

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAP1388

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Statistical Analysis Plan
  2. Informed Consent Form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Hip

Clinical Trials on Functional task-training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe