Erb PalsyNCT06460701
Effects of m-CIMT With and Without Kinesiotaping for Children With Erb's Palsy
A study testing m-CIMT without Kinesio taping and m-CIMT along with kinesiotaping in people with Erb Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The upper brachial plexus, a network of nerves in the neck and shoulder, is affected by Erb's palsy, often referred to as Erb-Duchenne palsy. This syndrome usually arises after labor, particularly if the baby's head and neck are pulled or stretched excessively during delivery. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Erb Palsy
- What is being tested?
- m-CIMT without Kinesio taping and m-CIMT along with kinesiotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Jun 2024to 1 Aug 2024
- 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of 2 years to 4 years.
- Children with Erb's palsy.
- Healthy BMI, ability to understand the command
- No previous mCIMT and kinesiotaping intervention was given
Who cannot join
- Children with visual deficits,
- Children with seizures or epilepsy,
- systemic disease or infectious disease,
- children with permanent arm deformities
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah international university
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Modified Constraint Induced Movement Therapy With and Without Kinesiotaping for Children With Erb's Palsy
The upper brachial plexus, a network of nerves in the neck and shoulder, is affected by Erb's palsy, often referred to as Erb-Duchenne palsy. This syndrome usually arises after labor, particularly if the baby's head and neck are pulled or stretched excessively during delivery. Erb's palsy can cause the hand and arm on the afflicted side of the body to become paralyzed or feeble. Erb's palsy symptoms can include: restricted range of motion in the injured arm. weakened hand and arm in the afflicted area, loss of feeling in the hand or arm. The effected arm is in "waiter's tip" position in which the elbow is bent and the wrist is flexed. The purpose of this research is to evaluate the effectiveness of modified constraint-induced movement therapy in children with erb's palsy, both with and without kinesiotaping.
Convenient sampling will be the method of sampling, and the study design will be randomized control trial. There will be two groups created with n = 40 subjects each. Twenty participants will be divided into two groups: twenty for each group will receive modified constraint-induced movement therapy plus kinesiotaping, while twenty for the other group will receive modified constraint-induced movement therapy alone. The youngsters will be evaluated using the Active Movement Scale.Both at the program's baseline and after the intervention is over, data will be gathered. The course of treatment will run for eight weeks straight, meeting three times a week for an hour each time. Based on inclusion criteria, subjects from Ayesha Amir Memorial Hospital and Children Hospital Faisalabad will be chosen. Data analysis will be done using SPSS 25.00.
Read the detailed description
Group A will be applied modified constraint induced movement therapy , session will last for one hour including following exercises such as ROM with the sling. Flexion, extension, abduction, and rotation of the shoulder. Flexion and extension of the elbow, Supination of forearm-Extension of wrist and finger. Stretching exercises for internal rotators , adductors ,extensors of shoulder. This will reduce the tightness and enhance the range of movement. Strengthening exercises also be applied to this group by throwing a ball in different directions above head position ,by drawing on paper stuck on the wall or window at different heights, by supinating bottles weighing <500g as tolerated by the child by thera band exercises above, across, and below the chest. Repetitive movement such as supinating the light bottles. Functional activities including some playful movement will be done by this group in which children are involved in different activities e.g playing with toys, blocks and such objects. Additionally, this group will engaged in a kinesiotaping program which aims to obtain more stability to the scapula on the affected side through facilitating middle and lower trapezius function. The shoulders will be kept in downward and back- ward position, while the alignment of scapulae should be manually maintained during the tape application. KT will set medially at the spinous processes (T2-T3 for middle trapezius and T12 for lower trapezius) and will be applied toward the acromion.
Group B will undergo same intervention such as group A alongwith m-CIMT but without the application of kinesiotaping.
There will be three sessions per week for the eight consecutive weeks.
- Conditions
- Erb Palsy
- Being tested
- m-CIMT without Kinesio taping, m-CIMT along with kinesiotaping
- Keywords
- Erb's Palsy ,, mCIMT, Kinesiotaping, OBPI .
- 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.
m-CIMT without Kinesio tapingOther
Baseline treatment m-CIMT will be applied includeing ROM with a sling, e.g shoulder flexion, extension, abduction, and rotation. The elbow's flexion and extension, Forearm supination is the extension of the wrist and fingers. Functional Training Using a tiny toy ball, practice tossing and catching it from various angles. Play with modeling clay, constructing towers of the toy bricks using LEGOs,Using crayons, ripping a piece of paper towel,Grasping biscuits, Using a spoon, utilizing a glass to drink, comb hair, brush teeth,Using a bubble blower,With a toy in hand, putting cap, putting lotion.stretching to shoulder's extensors, adductor, and internal rotators ,wrist and elbow flexors. strengthening exercises e.g a ball above head position in various directions,Using paper adhered to the window or wall at varying heights for drawing. The session will go for one hour.
m-CIMT along with kinesiotapingOther
Modified constraint-induced movement therapy along with kinesiotaping will be applied. m-CIMT protocol is baseline treatment and it is is same as in the other group.
This group also participated additionally in a kinesio taping program, which utilize KT with the goal of enhancing middle and lower trapezius function to increase stability in the scapula on the afflicted side. During the application of the tape, the shoulders were kept in a low and backward posture, and the scapular alignment was manually maintained. KT was administered at the acromion and positioned medially at the spinous processes (T2-T3 for the middle trapezius and T12 for the lower trapezius). For eight weeks in a row, there will be three sessions every week
| Study group | Role | What they receive |
|---|---|---|
| Active comparator: modified constraint induced movement therapy without Kinesiotaping. | Active comparator | in this group m-CIMT will be applied without kinesiotaping. Receives: Other: m-CIMT without Kinesio taping |
| Experimental: modified constraint induced movement therapy along with kinesio taping. | Experimental | in this group m-CIMT will be applied along with kinesiotaping. Receives: Other: m-CIMT along with kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Movement Scale
Active Movement Scale (AMS) is a unique assessment instrument that may be applied to children and newborns at any stage of development.. Tests are conducted for flexion, external rotation, internal rotation, abduction, and adduction of the shoulder, flexion and extension of the elbow, pronation and supination of the forearm, and flexion and extension of the wrist, finger, and thumb. AMS is measured on an 8-point scale (0 for no discernible contraction and 7 for full motion). For correct scoring, it is advised that the estimated passive range of motion (PROM) be confirmed using goniometry. Using kappa statistics, the scores were examined for reliability and chance agreement was managed. The 15 tested movements' overall kappa analysis revealed a moderate degree of score agreement (kappa = 0.51). Eight of the fifteen movements examined fell into the highest strength of agreement group (kappa(quad) = 0.81-1.00), according to quadratic-weighted kappa (kappa(quad)) statistics. Two movements
Measured: 8 weeks
Goniometer
A goniometer is a specialized tool used in physical therapy that measures and evaluates the range of motion (ROM) of joints in the human body. Physical therapists and other medical professionals use it as a vital tool for diagnosing, treating, and keeping track of a variety of musculoskeletal injuries, diseases, and rehabilitation processes. The findings showed good intra-rater reliability between sessions (ICC2,1 = 0.83 to 0.98), across sessions (ICC2,2 = 0.79 to 0.97), and high inter-rater reliability between sessions (ICC2,2 = 0.79 to 0.92).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start16 Jun 2024
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erb PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- it will be a randomized controlled trial in which non probability convenient sampling will be used. Two groups of 2-4 age will be formed in which participants will be randomly divided. Group A will receive m-CIMT along with kinesio taping while Group B will receive only m-CIMT.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Zaheer, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460701
- Sponsor's protocol ID
- REC/RCR&AHS/23/07104
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuran B, Azrak SD, Dogu B, Yilmaz F, Sirzai H, Oncu J, Terlemez R, Ayyildiz A. The Effect of the Modified Constraint-Induced Movement Therapy on the Upper Extremity Functions of Obstetric Brachial Plexus Palsy Patients. Sisli Etfal Hastan Tip Bul. 2022 Dec 19;56(4):525-535. doi: 10.14744/SEMB.2022.32956. eCollection 2022.
PubMed 36660395
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Modified Constraint Induced Movement Therapy With and Without Kinesiotaping for Children With Erb's Palsy
- ClinicalTrials.gov ID
- NCT06460701
- Acronym / sponsor ID
- REC/RCR&AHS/23/07104
- Conditions
- Erb Palsy
- Keywords
- Erb's Palsy ,, mCIMT, Kinesiotaping, OBPI .
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 14 Jun 2024 (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.
The upper brachial plexus, a network of nerves in the neck and shoulder, is affected by Erb's palsy, often referred to as Erb-Duchenne palsy. This syndrome usually arises after labor, particularly if the baby's head and neck are pulled or stretched excessively during delivery. Erb's palsy can cause the hand and arm on the afflicted side of the body to become paralyzed or feeble. Erb's palsy symptoms can include: restricted range of motion in the injured arm. weakened hand and arm in the afflicted area, loss of feeling in the hand or arm. The effected arm is in "waiter's tip" position in which the elbow is bent and the wrist is flexed. The purpose of this research is to evaluate the effectiveness of modified constraint-induced movement therapy in children with erb's palsy, both with and without kinesiotaping.
Convenient sampling will be the method of sampling, and the study design will be randomized control trial. There will be two groups created with n = 40 subjects each. Twenty participants will be divided into two groups: twenty for each group will receive modified constraint-induced movement therapy plus kinesiotaping, while twenty for the other group will receive modified constraint-induced movement therapy alone. The youngsters will be evaluated using the Active Movement Scale.Both at the program's baseline and after the intervention is over, data will be gathered. The course of treatment will run for eight weeks straight, meeting three times a week for an hour each time. Based on inclusion criteria, subjects from Ayesha Amir Memorial Hospital and Children Hospital Faisalabad will be chosen. Data analysis will be done using SPSS 25.00.
Detailed description
Group A will be applied modified constraint induced movement therapy , session will last for one hour including following exercises such as ROM with the sling. Flexion, extension, abduction, and rotation of the shoulder. Flexion and extension of the elbow, Supination of forearm-Extension of wrist and finger. Stretching exercises for internal rotators , adductors ,extensors of shoulder. This will reduce the tightness and enhance the range of movement. Strengthening exercises also be applied to this group by throwing a ball in different directions above head position ,by drawing on paper stuck on the wall or window at different heights, by supinating bottles weighing <500g as tolerated by the child by thera band exercises above, across, and below the chest. Repetitive movement such as supinating the light bottles. Functional activities including some playful movement will be done by this group in which children are involved in different activities e.g playing with toys, blocks and such objects. Additionally, this group will engaged in a kinesiotaping program which aims to obtain more stability to the scapula on the affected side through facilitating middle and lower trapezius function. The shoulders will be kept in downward and back- ward position, while the alignment of scapulae should be manually maintained during the tape application. KT will set medially at the spinous processes (T2-T3 for middle trapezius and T12 for lower trapezius) and will be applied toward the acromion.
Group B will undergo same intervention such as group A alongwith m-CIMT but without the application of kinesiotaping.
There will be three sessions per week for the eight consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- it will be a randomized controlled trial in which non probability convenient sampling will be used. Two groups of 2-4 age will be formed in which participants will be randomly divided. Group A will receive m-CIMT along with kinesio taping while Group B will receive only m-CIMT.
| Arm | Type | Receives |
|---|---|---|
| Active comparator: modified constraint induced movement therapy without Kinesiotaping. | Active comparator | Other: m-CIMT without Kinesio tapingin this group m-CIMT will be applied without kinesiotaping. |
| Experimental: modified constraint induced movement therapy along with kinesio taping. | Experimental | Other: m-CIMT along with kinesiotapingin this group m-CIMT will be applied along with kinesiotaping. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age of 2 years to 4 years.
- Children with Erb's palsy.
- Healthy BMI, ability to understand the command
- No previous mCIMT and kinesiotaping intervention was given
Key exclusion criteria (4 listed)
- Children with visual deficits,
- Children with seizures or epilepsy,
- systemic disease or infectious disease,
- children with permanent arm deformities
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 |
|---|---|---|
| m-CIMT without Kinesio tapingBaseline treatment m-CIMT will be applied includeing ROM with a sling, e.g shoulder flexion, extension, abduction, and rotation. The elbow's flexion and extension, Forearm supination is the extension of the wrist and fingers. Functional Training Using a tiny toy ball, practice tossing and catching it from various angles. Play with modeling clay, constructing towers of the toy bricks using LEGOs,Using crayons, ripping a piece of paper towel,Grasping biscuits, Using a spoon, utilizing a glass to drink, comb hair, brush teeth,Using a bubble blower,With a toy in hand, putting cap, putting lotion.stretching to shoulder's extensors, adductor, and internal rotators ,wrist and elbow flexors. strengthening exercises e.g a ball above head position in various directions,Using paper adhered to the window or wall at varying heights for drawing. The session will go for one hour. | Other | Active comparator: modified constraint induced movement therapy without Kinesiotaping. |
| m-CIMT along with kinesiotapingModified constraint-induced movement therapy along with kinesiotaping will be applied. m-CIMT protocol is baseline treatment and it is is same as in the other group. This group also participated additionally in a kinesio taping program, which utilize KT with the goal of enhancing middle and lower trapezius function to increase stability in the scapula on the afflicted side. During the application of the tape, the shoulders were kept in a low and backward posture, and the scapular alignment was manually maintained. KT was administered at the acromion and positioned medially at the spinous processes (T2-T3 for the middle trapezius and T12 for the lower trapezius). For eight weeks in a row, there will be three sessions every week | Other | Experimental: modified constraint induced movement therapy along with kinesio taping. |
Primary outcome
Active Movement Scale
Time frame: 8 weeks
Active Movement Scale (AMS) is a unique assessment instrument that may be applied to children and newborns at any stage of development.. Tests are conducted for flexion, external rotation, internal rotation, abduction, and adduction of the shoulder, flexion and extension of the elbow, pronation and supination of the forearm, and flexion and extension of the wrist, finger, and thumb. AMS is measured on an 8-point scale (0 for no discernible contraction and 7 for full motion). For correct scoring, it is advised that the estimated passive range of motion (PROM) be confirmed using goniometry. Using kappa statistics, the scores were examined for reliability and chance agreement was managed. The 15 tested movements' overall kappa analysis revealed a moderate degree of score agreement (kappa = 0.51). Eight of the fifteen movements examined fell into the highest strength of agreement group (kappa(quad) = 0.81-1.00), according to quadratic-weighted kappa (kappa(quad)) statistics. Two movements
Goniometer
Time frame: 8 weeks
A goniometer is a specialized tool used in physical therapy that measures and evaluates the range of motion (ROM) of joints in the human body. Physical therapists and other medical professionals use it as a vital tool for diagnosing, treating, and keeping track of a variety of musculoskeletal injuries, diseases, and rehabilitation processes. The findings showed good intra-rater reliability between sessions (ICC2,1 = 0.83 to 0.98), across sessions (ICC2,2 = 0.79 to 0.97), and high inter-rater reliability between sessions (ICC2,2 = 0.79 to 0.92).
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 29 Oct 2024.
- Background: PubMed 36660395Kuran B, Azrak SD, Dogu B, Yilmaz F, Sirzai H, Oncu J, Terlemez R, Ayyildiz A. The Effect of the Modified Constraint-Induced Movement Therapy on the Upper Extremity Functions of Obstetric Brachial Plexus Palsy Patients. Sisli Etfal Hastan Tip Bul. 2022 Dec 19;56(4):525-535. doi: 10.14744/SEMB.2022.32956. eCollection 2022.
- 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.
Anna Zaheer, MS principal investigator
Riphah International 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 m-CIMT without Kinesio taping and m-CIMT along with kinesiotaping in people with Erb Palsy, run by Riphah International University at 1 site in Pakistan.
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 4 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 29 Oct 2024. 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 Pakistan. 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?
Active Movement Scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460701, which also lists 1 linked publication.
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 29 Oct 2024.