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

Stretch-shortening Cycle Exercise: a Clinical Trial Investigating Its Role for Strength, Bone Mineral Density, and Functional Capacity in Children With Obstetric Brachial Plexus Injury

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.

Study Overview

• Status: Completed
• Conditions: Erb Palsy
• Intervention / Treatment: Other: Stretch-shortening exercise; Other: Standard exercise program

Detailed Description

Fifty-six children with OBPI were recruited from the Physical Therapy Outpatient Clinic of Prince Sattam Bin Abdulaziz University and three referral hospitals in Riyadh provenience, Saudi Arabia. The study included children who had a confirmed diagnosis of upper arm type of OBPI, classified as level I or II per Narakas classification system, aged 10-16 years, had a functional level of grade III according to the Mallet scoring system, and were consuming a balanced diet. Children who had a history of corrective neuromotor or musculoskeletal surgery, shoulder dislocation/subluxation, calcium supplements, or cognitive issues were excluded.

Outcome measures

1. Muscle strength: The peak isometric muscle strength of the shoulder flexors, abductors, external rotators, elbow flexors, and extensors was measured using a hand-held dynamometer.
2. Bone mineral properties: Bone mineral density and bone mineral content of the humeral, radial, and ulnar shafts were measured through Dual-Energy X-ray Absorptiometry (DEXA) scanning.
3. Upper-extremity function: The functional performance was assessed using the brachial plexus outcome measure (BPOM) activity scale.

The SSC-Ex group received a 12-week therapist-led SSC-Ex training, for approximately 35 minutes per session, two times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The SSC-Ex program consisted of ten unilateral and bilateral upper extremity exercises in the form of push-ups and ball slams/throws/passes activities. The SSC-Ex program preceded with a warm-up for 5 minutes and ended with a cool-down for 5 minutes. The control group received the standard exercise program, 35 minutes per session, two times a week for 12 consecutive weeks. The program consisted of flexibility exercises, strength training, weight-bearing exercises, proprioceptive neuromuscular facilitation, manual guidance, and functional training.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Kharj, Riyadh, Saudi Arabia
      • Ragab K. Elnaggar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SSC-Ex group; Children in this group received the SSC-Ex program	Other: Stretch-shortening exercise; 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.
Active Comparator: Control group; Children in this group received the standard exercise program.	Other: Standard exercise program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional performance	The affected arm functionality was assessed using the brachial plexus outcome measure. activity scale [an 11-item performance-based measure with five-point ordinal ratings for each item (I = cannot complete the task and 5 = complete the activity with normal pattern); higher scores denote better performance, with 55 being the maximum attainable score].	2 months

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Prince Sattam Bin Abdulaziz University
• Investigators: Principal Investigator: Ragab K. Elnaggar, PhD, Prince Sattam bin Abdulaziz University

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2021
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Brachial Plexus Neuropathies
• Other Study ID Numbers: RHPT/0021/0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No