Erb PalsyNCT06157476
Stretch-Shortening Cycle Exercise: Potential Implications For Children With Obstetric Brachial Plexus Injury
A study testing Stretch-shortening exercise and Standard exercise program in people with Erb Palsy, run by Cairo University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Erb Palsy
- What is being tested?
- Stretch-shortening exercise and Standard exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 14 Mar 2021to 23 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- 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.
- 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.
- 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.
- Conditions
- Erb Palsy
- Being tested
- Stretch-shortening exercise, Standard exercise program
- Medical subject headings
- Brachial Plexus Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stretch-shortening exerciseOther
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.
Standard exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SSC-Ex group | Experimental | Children in this group received the SSC-Ex program Receives: Other: Stretch-shortening exercise |
| Control group | Active comparator | Children in this group received the standard exercise program. Receives: Other: Standard exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
The peak isometric muscle strength (Kg) was measured using a hand-held dynamometer.
Measured: 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.
Measured: 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.
Measured: 2 months
Secondary outcomes (1)
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].
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start14 Mar 2021
- Primary completion23 Jun 2022
- Study completion23 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erb PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, two-arm, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K. Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157476
- Sponsor's protocol ID
- RHPT/0021/0015
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06157476
- Acronym / sponsor ID
- RHPT/0021/0015
- Conditions
- Erb Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Study start
- 14 Mar 2021 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, two-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| SSC-Ex group | Experimental | Other: Stretch-shortening exerciseChildren in this group received the SSC-Ex program |
| Control group | Active comparator | Other: Standard exercise programChildren in this group received the standard exercise program. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stretch-shortening exerciseThe 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. | Other | SSC-Ex group |
| Standard exercise programThe 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. | Other | Control group |
Primary outcome
Muscle strength
Time frame: 2 months
The peak isometric muscle strength (Kg) was measured using a hand-held dynamometer.
Bone mineral density
Time frame: 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
Time frame: 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.
1 secondary outcome
Functional performance
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Erb Palsy
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
Recruiting
Pilot Test of Caregiver Training Protocol for Brachial Plexus Birth Injury
Brachial Plexus Birth Palsy, Erbs Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K. Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stretch-shortening exercise and Standard exercise program in people with Erb Palsy, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.