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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT06157476
Collaborator
Prince Sattam Bin Abdulaziz University (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stretch-shortening exercise
  • Other: Standard exercise program
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A prospective, two-arm, randomized controlled trialA prospective, two-arm, randomized controlled trial
Masking:
Single (Outcomes Assessor)
Masking Description:
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 14, 2021
Actual Primary Completion Date :
Jun 23, 2022
Actual Study Completion Date :
Jun 23, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Muscle strength [2 months]

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

  2. Bone mineral density [2 months]

    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.

  3. Bone mineral content [2 months]

    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.

Secondary Outcome Measures

  1. Functional performance [2 months]

    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].

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ragab K. Elnaggar Al Kharj Riyadh Saudi Arabia

Sponsors and Collaborators

  • Cairo University
  • Prince Sattam Bin Abdulaziz University

Investigators

  • Principal Investigator: Ragab K. Elnaggar, PhD, Prince Sattam Bin Abdulaziz University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ragab Kamal Elnaggar, Professor, Cairo University
ClinicalTrials.gov Identifier:
NCT06157476
Other Study ID Numbers:
  • RHPT/0021/0015
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2023