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Obstetric; InjuryNCT05411731

Modified Constraint Induced Movement Therapy in Children With Obstetric Brachial Plexus Injury

A study testing Conventional physical therapy treatment and Constraint induced movement therapy in people with Obstetric; Injury, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study was to increase and improve the use of affected extremity in obstetric brachial plexus palsy children while restricting the use of less affected arm and the purpose was to improve the function, Range of motion and disability in affected arm of children with brachial plexus injury. Read more about this study

Who is it for?
Ages 3 to 10 years
Conditions the study is for
Obstetric; Injury
What is being tested?
Conventional physical therapy treatment and Constraint induced movement therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 sitePakistan
Study dates
30 Apr 2022to 1 Sep 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 3 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 3 to 10 years
  • Both genders will be included
  • Deficiency of shoulder abduction and external rotation
  • Who can follows command

Who cannot join

  • uncontrolled seizures
  • Orthopedic and/or neurological surgery.
  • A visual impairment interfering with treatment/testing.
  • Unable to actively engage in assessment process

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Bakhtawar Amin Trust Teaching Hospital

    Multan Khurd, Punjab Province, 59300

Other trials in Pakistan

About this study

Official title: Effect of Modified Constraint Induced Movement Therapy on Range of Motion, Function and Disability in Children With Obstetric Brachial Plexus Injury

The aim of this study was to increase and improve the use of affected extremity in obstetric brachial plexus palsy children while restricting the use of less affected arm and the purpose was to improve the function, Range of motion and disability in affected arm of children with brachial plexus injury.

Being tested
Conventional physical therapy treatment, Constraint induced movement therapy
Keywords
birth injuries therapy, arm function, constraint induced movement therapy, brachial plexus neuropathies
Medical subject headings
Wounds and Injuries, Brachial Plexus Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional physical therapy treatmentOther

    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

  • Constraint induced movement therapyOther

    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.

Study groups in NCT05411731
Study groupRoleWhat they receive
Conventional physical therapy treatmentActive comparatorPatients in this group will receive conventional physical therapy i.e. stretching, strengthening exercises, Aeroplan positioning
Receives: Other: Conventional physical therapy treatment
Constraint induced movement therapyExperimentalpatients of this group will receive the same treatment along with constraint induced movement therapy
Receives: Other: Constraint induced movement therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mallet grading system

    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.

    Measured: 4 weeks

Secondary outcomes (2)

  1. goniometer

    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.

    Measured: 4th week

  2. Upper extremity function index

    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:

    • Extreme difficulty or unable to perform activity (0 points);
    • Quite a bit of difficulty (1 point);
    • Moderate difficulty (2 points);
    • A little bit of difficulty (3 points);
    • No difficulty (4 points).

    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.

    Measured: 4th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start30 Apr 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05411731
Sponsor's protocol ID
REC/RCR&AHS/22/0701
Status last verified
Mar 2023
First submitted
6 Jun 2022
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33894122

  • 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.

    PubMed 34955793

  • 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.

    PubMed 6038856

  • 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.

    PubMed 27984470

  • 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.

    PubMed 32151503

  • 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.

    PubMed 25841560

  • 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.

    PubMed 21603848

  • 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.

    PubMed 29199193

  • 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.

    PubMed 31814455

  • 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.

    PubMed 34649982

  • 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.

    PubMed 33219706

Questions about this trial

What is this clinical trial studying?

A study testing Conventional physical therapy treatment and Constraint induced movement therapy in people with Obstetric; Injury, 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 17 Mar 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 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?

Mallet grading system (time frame: 4 weeks). 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 NCT05411731, which also lists 11 linked publications.

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 17 Mar 2023.

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