- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05947110
Plyometric-Based Hydro-Kinesio Therapy in Children With Hemophilic Arthropathy
How Effective is the Plyometric-based Hydro-kinesio Therapy for Pain, Muscle Strength, Postural Control, and Functional Performance in Children With Hemophilic Knee Arthropathy?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Forty-eight boys with moderate hemophilia-A were recruited from the hematology clinics of three large referral hospitals in Riyadh, Saudi Arabia. The study included patients who were 8-16 years old, had factor VIII replacement prophylaxis, were clinically-stable cases, had unilateral knee hemarthrosis, had grade II or III knee arthropathy, had muscle strength of grade three, and if they were able to walk independently. Patients who had enduring disabling pain, fixed deformities, a history of musculoskeletal surgery, visual and/or vestibular deficits, or bleeding episodes within two weeks before enrollment were excluded.
Outcome measures
Pain: Pain during rest and/or movement was assessed using the Numerical Pain Rating Scale.
Muscle strength: The peak concentric torque of the quadriceps and hamstring muscles was measured through an Isokinetic Dynamometer.
Postural control: The directional dynamic limit of stability (forward, backward, affected, and non-affected) and overall limit of stability were assessed using the Biodex balance system.
Functional performance: The extent of functional capacity was assessed through the functional independence score in hemophilia and the six-minute walk test.
Interventions
The Plyo-HKT group received the Plyo-HKT program, 45 minutes per session, two times a week for 8 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The Plyo-HKT program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities conducted in a water medium. The Plyo-HKT included a warm-up for 10 minutes and a cool-down for 5 minutes. The control group received the standard exercise program, 45 minutes per session, two times a week for 8 consecutive weeks. The program consisted of flexibility exercise, strength training, weight-bearing, proprioceptive training, and free treadmill walking or cycle ergometry.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Riyadh
-
Al Kharj, Riyadh, Saudi Arabia
- Ragab K. Elnaggar
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eight and 16 years.
- Had factor VIII replacement prophylaxis.
- Clinically-stable.
- Unilateral knee involvement.
- Knee arthropathy of grade II or III per the Arnold-Hilgartner radiographic classification.
- Muscle strength of grade 3 in lower limb muscles.
- Use of no pain medication for one month prior to enrollment.
- Walking independently.
Exclusion Criteria:
- Enduring disabling pain
- Fixed deformities.
- History of musculoskeletal surgery.
- Visual or vestibular deficits.
- Engagement in regular exercises.
- Bleeding episodes within two weeks prior to enrolment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
Participants in this group received the standard exercise program.
|
The program encompassed the standard exercises for patients with JIA (aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises).
The training was conducted for 45 minutes, two times a week for 8 successive weeks.
|
|
Experimental: Plyo-HKT group
Participants in this group received the Plyo-HKT program
|
The plyometric-based hydro-kinesio therapy was conducted for 45 minutes, twice weekly, for 8 successive weeks.
The training was geared toward the lower body and was conducted under the close supervision of a licensed pediatric physical therapist in accordance with the safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: 2 months
|
Participants reported how much they feel pain during rest and/or movement on the 0-10 Numerical Pain Rating Scale, where 0 represents "no pain" and 10 indicates the "worst possible pain".
|
2 months
|
|
Muscle strength
Time Frame: 2 months
|
Indicated by the peak concentric torque of the quadriceps and hamstring muscles (Nm).
It was measured using an Isokinetic Dynamometer.
|
2 months
|
|
Postural control
Time Frame: 2 months
|
The capacity to control and move the center of gravity in various directions across the base of support was assessed utilizing the Biodex balance system.
Values are expressed as accuracy % and higher scores mean better balance capability.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-minute walk test
Time Frame: 2 months
|
The six-minute walk test measured the walking distance that children were able to cover across a 30-m walkway with a self-determined walking pace over six minutes.
A longer distance indicates a better performance.
|
2 months
|
|
Functional independence
Time Frame: 2 months
|
The functional independence was assessed using the Functional Independence Score in Hemophilia.
The test includes an assessment of eight activities, divided into three categories (selfcare, transfer, and mobility).
Each activity is rated on a 1-4 scale, where 1 indicates that participant was unable to execute the action or requires full support and 4 indicates being able to do the task without any difficulties.
The maximum score is 32, which denotes the highest degree of independence.
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ragab K Elnaggar, PhD, Prince Sattam bin Abdulaziz University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/0021/0033
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Haemophilic Arthropathy of Knee
-
University of PalermoCompletedOrthosis | Haemophilic Arthropathy | Foot MalalignmentItaly
-
Universidad de ZaragozaCompletedArthropathy of Knee | Arthropathy of HipSpain
-
Centre Hospitalier Universitaire de la RéunionCompletedArthropathy of Knee | Arthropathy of HipRéunion
-
Super Inspired LLCRecruitingArthropathy of Knee | Arthropathy of HipUnited States
-
Medical University of South CarolinaCompletedArthropathy of Knee | Arthropathy of HipUnited States
-
Hvidovre University HospitalCompletedArthropathy of Knee | Arthropathy of HipDenmark
-
Hôpital Privé SévignéActive, not recruitingArthropathy of Knee | Arthropathy of HipFrance
-
Diskapi Teaching and Research HospitalCompletedArthropathy of Knee | Arthropathy of HipTurkey
-
Stryker OrthopaedicsActive, not recruitingKnee Arthritis | Arthropathy of Knee | ReplacementUnited States
-
University of PennsylvaniaSuspendedArthropathy of Knee Joint | Arthropathy of Hip JointUnited States
Clinical Trials on Plyometric-based hydro-kinesio therapy
-
Cairo UniversityCompletedCerebral PalsySaudi Arabia
-
University of ManoubaCompleted
-
Nourhan Atwa SaidCairo UniversityRecruitingOsteoarthritis | Knee Osteoarthritis (Knee OA)Egypt
-
Cairo UniversityCompletedCerebral PalsySaudi Arabia
-
Cairo UniversityCompletedCerebral PalsySaudi Arabia
-
Faculdade de Ciências Médicas da Santa Casa de...Completed
-
Riphah International UniversityCompleted
-
Universidade Cidade de Sao PauloCompletedNonspecific Chronic Low Back PainBrazil
-
Cairo UniversityCompletedSports Physical TherapyEgypt
-
Cairo UniversityCompletedSports Physical TherapyEgypt