Clinical trial NCT06157476: Stretch-Shortening Cycle Exercise: Potential Implications For Children With Obstetric Brachial Plexus Injury
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erb Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Prince Sattam Bin Abdulaziz University
First posted: 2023-12-05
Enrollment: 56
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, two-arm, randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Muscle strength
timeFrame: 2 months
measure: Bone mineral density
timeFrame: 2 months
measure: Bone mineral content
timeFrame: 2 months
Secondary outcomes:
measure: Functional performance
timeFrame: 2 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Ragab K. Elnaggar
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Ragab K. Elnaggar, PhD
role: PRINCIPAL_INVESTIGATOR
References: