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临床试验/NCT06157476
NCT06157476已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2021年3月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Muscle strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Muscle strength

时间窗: 2 months

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

Bone mineral density

时间窗: 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.

Bone mineral content

时间窗: 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.

次要结局

  • Functional performance(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ragab Kamal Elnaggar

Professor

Cairo University

研究点 (1)

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