Plyometric-Based Hydro-Kinesio Therapy in Children With Hemophilic Arthropathy

NCT05947110 | Completed

• 1 other identifier: RHPT/0021/0033
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to assess the effect of an 8-week plyometric-based hydro-kinesio therapy (Plyo-HKT) on pain, muscle strength, postural control, and functional performance in a convenience sample of children with hemophilic knee arthropathy (HKA). Forty-eight patients with HKA were randomly allocated to the Plyo-HKT group (n = 24, received the plyometric-based hydro-kinesio therapy program, twice/week, over 8 weeks) or the control group (n = 24, received standard exercise program). Both groups were assessed for pain, muscle strength, postural control, and functional performance pre and post-treatment.

Conditions

Haemophilic Arthropathy of Knee

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  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

  Indicated by the peak concentric torque of the quadriceps and hamstring muscles (Nm). It was measured using an Isokinetic Dynamometer.

  2 months

• Postural control

  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 Outcomes (2)

• Functional independence

  2 months

• Six-minute walk test

  2 months

Study Arms (2)

Plyo-HKT group

EXPERIMENTAL

Participants in this group received the Plyo-HKT program

Other: Plyometric-based hydro-kinesio therapy

Control group

ACTIVE COMPARATOR

Participants in this group received the standard exercise program.

Other: Standard exercise therapy

Interventions

Plyometric-based hydro-kinesio therapy OTHER

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.

Plyo-HKT group

Standard exercise therapy OTHER

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.

Control group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

Study Officials

• Ragab K Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This was a single-blind protocol. The researcher who collected the data was blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A prospective, randomized controlled clinical trial

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: September 5, 2021
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

SA (1)