- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05411731
Modified Constraint Induced Movement Therapy in Children With Obstetric Brachial Plexus Injury
Effect of Modified Constraint Induced Movement Therapy on Range of Motion, Function and Disability in Children With Obstetric Brachial Plexus Injury
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
conducted a study that included data of 19 children with Brachial Plexus Birth Injury (4.1 years) and 18 with unilateral Cerebral Palsy (4.5 years) were compared. The effects of modified constraint-induced-movement-therapy with bimanual training (54 h modified constraint-induced-movement-therapy, 18 h bimanual training, 8-10 weeks) was investigated Children with Brachial Plexus Birth Injury showed significant improvements on all outcome measures following modified constraint-induced-movement-therapy with bimanual training. These results were comparable to those observed in the group of children with unilateral Cerebral Palsy.
Comparison of the efficacy of electrotherapy and neuromuscular retraining techniques in restoring function of children with obstetric palsy The purpose of this review is to describe and compare recent research data on the efficacy of electrotherapy and neuromuscular retraining techniques in the rehabilitation of infants with OP. : Electrotherapy and neuromuscular retraining techniques are equally useful methods for treating OP.
A Single-blinded Randomized Controlled Trial 24 subacute stroke patients were randomly assigned to the experimental group or the control group (n = 12 each) to explore the Effects of Action Observation Combined with Modified Constraint-induced Movement Therapy on Upper-extremity Function of moderate Subacute Stroke Patients. Experimental group watched video clips for 10 minutes related to tasks performed during modified constraint-induced movement therapy while the control group watched videos with modified: constraint-induced movement therapy may be a beneficial rehabilitation option to improve upper-extremity function in subacute stroke patients with moderate constraint induced movement therapy has been studied in unilateral disabilities of brain injuries but modified constraint induced movement therapy had little studies in improving arm function, ROM and disability due to obstetric brachial plexus injuries in children. It can be studied in other unilateral neurological conditions as well.
For bimanual activity performance, CIMT is preferred over normal care. A longer follow-up period, more comparator therapies, and assessments of variations by participant characteristics should all be investigated in future study of different neurological conditions of brain injuries affecting upper as well as lower limb impairment.
conducted a study that evaluated the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. 22 Participants were randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one. A passive constraint cast was applied to the participants unaffected rm for 8 weeks' scale was used to assess the bimanual care of brachial plexus participants of 12 months to 5 years were included they concluded in his study that mCIMT was more effective than usual care.
A randomized double blinded clinical trail Early non-invasive brain stimulation with modified constraint-induced movement therapy for motor and functional upper limb recovery in stroke patients: adults below 8 years, at least 2 days post unihemispheric stroke event, with hemiparesis. Modified constraint-induced movement therapy plus transcranial direct-current stimulation in subacute stroke patients with hemiparesis could maximize motor and functional recovery.
2021 conducted a randomized control trial Constraint-Induced Movement Therapy for Cerebral Palsy with Children of Hemiparesis compared 2 doses and 2 constraint types of constraint-induced movement therapy (CIMT) to usual customary treatment (UCT). randomly assigned 118 2- to 8-year-olds with hemiparetic cerebral palsy to one of 5 treatments with assessments at baseline, end of treatment, and 6 months posttreatment. Primary blinded outcomes were the assisting hand assessment; Peabody Motor Development Scales results revealed high-dose CIMT produced significantly greater improvement than a moderate dose or Usual customary care.
effect of Modified constraint-induced movement therapy during hospitalization in children with perinatal brachial plexus palsy that concluded that mCIMT has a potential to promote functional gains for children with PBPP; this approach should be widely applied within routine clinical practice Constraint-Induced Movement Therapy for Children with Brain Tumors The purpose of this pilot study was to investigate the feasibility of a 3-week constraint-induced movement therapy program in 9 children with brain tumors and upper extremity hemiplegia and to describe change in extremities Findings suggest that a child with hemiplegia as a result of a brain tumor can adhere to and benefit from a CIMT program.
Therapeutic application of electrical stimulation and constraint induced movement therapy in perinatal brachial plexus injury: A case report study in infants and children with perinatal brachial plexus injury (PBPI) was conducted. Electrical stimulation:
and constraint induced movement therapy provided sequentially were effective therapy interventions.
Effect of modified constrained induced movement therapy on improving arm function in children with obstetric brachial plexus injury. They concluded that the modified constraint movement therapy was the more effective method on improving the arm function in children with OBP
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Multān, Punjab, Pakistan, 59300
- Bakhtawar Amin Trust Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 3 to 10 years
- Both genders will be included
- Deficiency of shoulder abduction and external rotation
- Who can follows command
Exclusion Criteria:
- uncontrolled seizures
- Orthopedic and/or neurological surgery.
- A visual impairment interfering with treatment/testing.
- Unable to actively engage in assessment process
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional physical therapy treatment
Patients in this group will receive conventional physical therapy i.e. stretching, strengthening exercises, Aeroplan positioning
|
The control group (group A) will receive the exercise program which focused on improving the arm function as well as shoulder abduction and external rotation for 10 week. stretching Aeroplan positioning |
|
Experimental: Constraint induced movement therapy
patients of this group will receive the same treatment along with constraint induced movement therapy
|
The study group (group B) who will receive Modified constraint induced movement therapy for 3 hrs.
a day 12 hrs.
a week in addition to the same exercise program given to the control group for 10 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mallet grading system
Time Frame: 4 weeks
|
The Mallet grading system is a commonly used functional scoring system to assess shoulder abduction/external rotation deficits in children with obstetric brachial plexus palsy.
One feature of the Mallet score is that each grade is translated in to certain degree of deficiencies in both shoulder abduction and external rotation.
A scale of 1 to 5 is used to evaluate shoulder abduction, global external rotation, and hand to neck, hand to back, and hand to mouth positions.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
goniometer
Time Frame: 4th week
|
changes from the baseline ROM of shoulder abduction and external rotation as well as elbow ranges was measured by goniometer was measured by can evaluate both active as well as passive range of motion.
|
4th week
|
|
Upper extremity function index
Time Frame: 4th week
|
It is a self-administered questionnaire which measures disability in people with upper extremity orthopaedic conditions. The questionnaire lists 20 activities and the patient gives a score to each based on the difficulty they have completing that activity. It is evaluated on a 5-point scale that refers to the perceived difficulty in performing the mentioned action:
The overall Upper extremity function index (UEFI) result ranges between 0 and 80, where 0 indicates most severe limitation and 80 suggests least limitation. Changes from baseline function of affected extremity was given by this tool. |
4th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hafiza Mehjabeen, ppdpt, Riphah International University
Publications and helpful links
General Publications
- El-Shamy S, Alsharif R. Effect of virtual reality versus conventional physiotherapy on upper extremity function in children with obstetric brachial plexus injury. J Musculoskelet Neuronal Interact. 2017 Dec 1;17(4):319-326.
- Pejkova S, Filipce V, Peev I, Nikolovska B, Jovanoski T, Georgieva G, Srbov B. Brachial Plexus Injuries - Review of the Anatomy and the Treatment Options. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2021 Apr 23;42(1):91-103. doi: 10.2478/prilozi-2021-0008.
- Souza L, Lustosa L, Silva AEL, Martins JV, Pozzo T, Vargas CD. Kinematic Changes in the Uninjured Limb After a Traumatic Brachial Plexus Injury. Front Hum Neurosci. 2021 Dec 9;15:777776. doi: 10.3389/fnhum.2021.777776. eCollection 2021.
- Adler JB, Patterson RL Jr. Erb's palsy. Long-term results of treatment in eighty-eight cases. J Bone Joint Surg Am. 1967 Sep;49(6):1052-64. No abstract available.
- Sparrow J, Zhu L, Gajjar A, Mandrell BN, Ness KK. Constraint-Induced Movement Therapy for Children With Brain Tumors. Pediatr Phys Ther. 2017 Jan;29(1):55-61. doi: 10.1097/PEP.0000000000000331.
- Eren B, Karadag Saygi E, Tokgoz D, Akdeniz Leblebicier M. Modified constraint-induced movement therapy during hospitalization in children with perinatal brachial plexus palsy: A randomized controlled trial. J Hand Ther. 2020 Jul-Sep;33(3):418-425. doi: 10.1016/j.jht.2019.12.008. Epub 2020 Mar 7.
- Berggren J, Baker LL. Therapeutic application of electrical stimulation and constraint induced movement therapy in perinatal brachial plexus injury: A case report. J Hand Ther. 2015 Apr-Jun;28(2):217-20; quiz 221. doi: 10.1016/j.jht.2014.12.006. Epub 2014 Dec 17.
- Wang Q, Zhao JL, Zhu QX, Li J, Meng PP. Comparison of conventional therapy, intensive therapy and modified constraint-induced movement therapy to improve upper extremity function after stroke. J Rehabil Med. 2011 Jun;43(7):619-25. doi: 10.2340/16501977-0819.
- Zielinski IM, van Delft R, Voorman JM, Geurts ACH, Steenbergen B, Aarts PBM. The effects of modified constraint-induced movement therapy combined with intensive bimanual training in children with brachial plexus birth injury: a retrospective data base study. Disabil Rehabil. 2021 Aug;43(16):2275-2284. doi: 10.1080/09638288.2019.1697381. Epub 2019 Dec 8.
- Ramey SL, DeLuca SC, Stevenson RD, Conaway M, Darragh AR, Lo W; CHAMP. Constraint-Induced Movement Therapy for Cerebral Palsy: A Randomized Trial. Pediatrics. 2021 Nov;148(5):e2020033878. doi: 10.1542/peds.2020-033878. Epub 2021 Oct 14.
- Werner JM, Berggren J, Loiselle J, Lee GK. Constraint-induced movement therapy for children with neonatal brachial plexus palsy: a randomized crossover trial. Dev Med Child Neurol. 2021 May;63(5):545-551. doi: 10.1111/dmcn.14741. Epub 2020 Nov 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/22/0701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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