Stretch-Shortening Cycle Exercise: Potential Implications For Children With Obstetric Brachial Plexus Injury

NCT06157476 | Completed

• 1 other identifier: RHPT/0021/0015
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study was set out to evaluate the effect of a 12-week stretch-shortening cycle exercise (SSC-Ex) on muscle strength, bone mineral density, and upper extremity function in children with obstetric brachial plexus injury (OBPI). Fifty-six patients with OBPI were randomly allocated to the SSC-Ex group (n = 28, received SSC-Ex program, twice/week, over 12 weeks) or the control group (n = 28, received standard exercise program). Both groups were assessed for muscle strength, bone health, and upper extremity function before and after treatment.

Conditions

Erb Palsy

Outcome Measures

Primary Outcomes (3)

• Muscle strength

  The peak isometric muscle strength (Kg) was measured using a hand-held dynamometer.

  2 months

• Bone mineral density

  The amount of bone mineral divided by the bone scanned area (gm/cm2). It was assessed within the humeral, radial, and ulnar shafts using DEXA scanning.

  2 months

• Bone mineral content

  It is the amount of bone mineral in bone tissue (g/cm). It was calculated by summing the bone mineral density values over the projected area. It was also measured within the humeral, radial, and ulnar shafts using DEXA scanning.

  2 months

Secondary Outcomes (1)

• Functional performance

  2 months

Study Arms (2)

SSC-Ex group

EXPERIMENTAL

Children in this group received the SSC-Ex program

Other: Stretch-shortening exercise

Control group

ACTIVE COMPARATOR

Children in this group received the standard exercise program.

Other: Standard exercise program

Interventions

Stretch-shortening exercise OTHER

The SSC-Ex program was conducted for 35 minutes/session twice weekly over 12 weeks. The program was directed by a 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. The program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities and was preceded by a warm-up for 5 minutes and ended with a cool-down for 5 minutes.

SSC-Ex group

Standard exercise program OTHER

The standard exercise program lasted for 35 minutes/session and repeated two times a week for 12 consecutive weeks. The program was conducted by a pediatric physical therapist and consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, manual guidance, and functional training.

Control group

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Confirmed diagnosis of upper arm type of OBPI.
• Narakas classification level I or II.
• Functional level of grade III per the Mallet scoring system.
• Age between 10-16 years.

You may not qualify if:

• History of neuromotor or musculoskeletal surgery.
• Shoulder subluxation/dislocation.
• Past fracture involving the upper extremities.
• Calcium supplement intake.
• Inability to adhere to the scheduled program.

Sponsors & Collaborators

• Cairo University: lead
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Brachial Plexus Neuropathies

Interventions

Plyometric Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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 blind to the allocation of treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, two-arm, randomized controlled trial

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 5, 2023
• Study Start: March 14, 2021
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)