The Effect of Upper Limb Loading During Partial Body Weight Support Treadmill Training in Children With Cerebral Palsy

NCT05444387 | Unknown DMC

• 1 other identifier: U19102427
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: To look for the effect of upper limb loading with external weights during partial body weight support treadmill training on gait speed, gait endurance and trunk control. Hypothesis: Investigator's hypothesis is that loading the upper limb with 1 lb. external weights during partial body weight support treadmill training is more effective than partial body weight support treadmill training without loading of the upper limbs in improving gait speed, gait endurance and trunk control.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• Change from Baseline 10-meters walk test at 6 weeks

  It it a measure of walking performance because it has been shown to 1- provide a useful measure of walking endurance, 2- be a representative measure of a child's community walking speed, and 3- have 95% confidence interval (CI 0.77-0.99) in children with CP. 4- valid.

  At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)

• Change from Baseline Trunk Control Measurement scale at 6 weeks

  It measures the trunk control level as it helps in differentiating between children who are independent in self-care and mobility and those who are not, it is valid, and it has a good reliability in children with neurological disorders. Trunk control Measurement Scale (TCMS) is an objective outcome measure to score trunk ability in sitting. It does consists of static and dynamic sitting balance; the latter is divided into selective movement control and dynamic reaching. The maximum value is 58 and the minimum is 0. Higher values correlate to better outcomes.

  At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)

Study Arms (2)

Upper Limb Loading Group

EXPERIMENTAL

Partial body weight support treadmill training with upper limb external weights in addition to conventional treatment: balance, gait training, facilitation for normal development

Other: Upper limb loading

Control Group

NO INTERVENTION

Partial body weight support treadmill training without upper limb external weights in addition to conventional treatment: balance, gait training, facilitation for normal development

Interventions

Upper limb loading OTHER

1 lb. external weight will be wrapped around both wrists during partial body weight support treadmill training. The partial body weight support treadmill training will be given for a maximum of 30 minutes and will finish earlier if the child asked to stop, or if the child stopped stepping. Body weight support will be systematically reduced, walking speed will be progressively increased over the training period, upright standing posture will be emphasized and normal kinematic components of the gait cycle will be facilitated during the training session. The training protocol for the current study will consist of 2 training sessions per weeks with at least one day in between and will last for 6 weeks.

Upper Limb Loading Group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of CP confirmed by the neurologist
• Age between 4 to 8 years
• Both genders
• The level of gross motor function is between level I and II according to Gross Motor Function Classification System (GMFCS)
• The degree of spasticity according to Modified Ashworth Scale range between grade 1 and grade 2
• Children should be cognitively competent with IQ level not less than 60% and able to understand and follow instructions, as well as, in general they are cooperative
• Only Arabic and English speakers will be recruited in the study

You may not qualify if:

• Had any orthopedic surgery or spasticity altering procedure in the previous 12 months
• Children with visual, auditory, vestibular or perceptual deficits.

Sponsors & Collaborators

• Alya Abdelghafour Alkhajeh: lead

Study Sites (1)

Al Qassimi Women's and Children's Hospital

Sharjah city, United Arab Emirates

Location

Related Publications (62)

• Rosenbaum PL, Walter SD, Hanna SE, Palisano RJ, Russell DJ, Raina P, Wood E, Bartlett DJ, Galuppi BE. Prognosis for gross motor function in cerebral palsy: creation of motor development curves. JAMA. 2002 Sep 18;288(11):1357-63. doi: 10.1001/jama.288.11.1357.

  PMID: 12234229 BACKGROUND

• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  PMID: 17370477 BACKGROUND

• Drougia A, Giapros V, Krallis N, Theocharis P, Nikaki A, Tzoufi M, Andronikou S. Incidence and risk factors for cerebral palsy in infants with perinatal problems: a 15-year review. Early Hum Dev. 2007 Aug;83(8):541-7. doi: 10.1016/j.earlhumdev.2006.10.004. Epub 2006 Dec 26.

  PMID: 17188824 BACKGROUND

• Ostojic K, Paget SP, Morrow AM. Management of pain in children and adolescents with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Mar;61(3):315-321. doi: 10.1111/dmcn.14088. Epub 2018 Oct 31.

  PMID: 30378122 BACKGROUND

• Yu Y, Chen X, Cao S, Wu D, Zhang X, Chen X. Gait synergetic neuromuscular control in children with cerebral palsy at different gross motor function classification system levels. J Neurophysiol. 2019 May 1;121(5):1680-1691. doi: 10.1152/jn.00580.2018. Epub 2019 Mar 20.

  PMID: 30892974 BACKGROUND

• Pinto TPS, Fonseca ST, Goncalves RV, Souza TR, Vaz DV, Silva PLP, Mancini MC. Mechanisms contributing to gait speed and metabolic cost in children with unilateral cerebral palsy. Braz J Phys Ther. 2018 Jan-Feb;22(1):42-48. doi: 10.1016/j.bjpt.2017.06.015. Epub 2017 Jul 5.

  PMID: 28728959 BACKGROUND

• Degelaen M, De Borre L, Buyl R, Kerckhofs E, De Meirleir L, Dan B. Effect of supporting 3D-garment on gait postural stability in children with bilateral spastic cerebral palsy. NeuroRehabilitation. 2016 Jun 23;39(2):175-81. doi: 10.3233/NRE-161349.

  PMID: 27341370 BACKGROUND

• Sewell MD, Eastwood DM, Wimalasundera N. Managing common symptoms of cerebral palsy in children. BMJ. 2014 Sep 25;349:g5474. doi: 10.1136/bmj.g5474. No abstract available.

  PMID: 25255910 BACKGROUND

• Keeratisiroj O, Thawinchai N, Siritaratiwat W, Buntragulpoontawee M, Pratoomsoot C. Prognostic predictors for ambulation in children with cerebral palsy: a systematic review and meta-analysis of observational studies. Disabil Rehabil. 2018 Jan;40(2):135-143. doi: 10.1080/09638288.2016.1250119. Epub 2016 Nov 16.

  PMID: 27848255 BACKGROUND

• Colver A, Fairhurst C, Pharoah PO. Cerebral palsy. Lancet. 2014 Apr 5;383(9924):1240-9. doi: 10.1016/S0140-6736(13)61835-8. Epub 2013 Nov 20.

  PMID: 24268104 BACKGROUND

• Taflampas G, Kilbride C, Levin W, Lavelle G, Ryan JM. Interventions to Improve or Maintain Lower-Limb Function Among Ambulatory Adolescents with Cerebral Palsy: A Cross-Sectional Survey of Current Practice in the UK. Phys Occup Ther Pediatr. 2018 Nov;38(4):355-369. doi: 10.1080/01942638.2017.1400490. Epub 2017 Dec 8.

  PMID: 29220616 BACKGROUND

• Shepherd, R., & Carr, J. (1999). Treadmill Walking in Neurorehabilitation. Neurorehabilitation and Neural Repair, 13(3), 171-173. doi:10.1177/154596839901300303

  BACKGROUND

• DePaul VG, Wishart LR, Richardson J, Lee TD, Thabane L. Varied overground walking-task practice versus body-weight-supported treadmill training in ambulatory adults within one year of stroke: a randomized controlled trial protocol. BMC Neurol. 2011 Oct 21;11:129. doi: 10.1186/1471-2377-11-129.

  PMID: 22018267 BACKGROUND

• Sousa CO, Barela JA, Prado-Medeiros CL, Salvini TF, Barela AM. Gait training with partial body weight support during overground walking for individuals with chronic stroke: a pilot study. J Neuroeng Rehabil. 2011 Aug 24;8:48. doi: 10.1186/1743-0003-8-48.

  PMID: 21864373 BACKGROUND

• Sullivan KJ, Knowlton BJ, Dobkin BH. Step training with body weight support: effect of treadmill speed and practice paradigms on poststroke locomotor recovery. Arch Phys Med Rehabil. 2002 May;83(5):683-91. doi: 10.1053/apmr.2002.32488.

  PMID: 11994808 BACKGROUND

• Hesse S, Konrad M, Uhlenbrock D. Treadmill walking with partial body weight support versus floor walking in hemiparetic subjects. Arch Phys Med Rehabil. 1999 Apr;80(4):421-7. doi: 10.1016/s0003-9993(99)90279-4.

  PMID: 10206604 BACKGROUND

• Gama GL, Celestino ML, Barela JA, Forrester L, Whitall J, Barela AM. Effects of Gait Training With Body Weight Support on a Treadmill Versus Overground in Individuals With Stroke. Arch Phys Med Rehabil. 2017 Apr;98(4):738-745. doi: 10.1016/j.apmr.2016.11.022. Epub 2016 Dec 27.

  PMID: 28034719 BACKGROUND

• Ganesan M, Sathyaprabha TN, Pal PK, Gupta A. Partial Body Weight-Supported Treadmill Training in Patients With Parkinson Disease: Impact on Gait and Clinical Manifestation. Arch Phys Med Rehabil. 2015 Sep;96(9):1557-65. doi: 10.1016/j.apmr.2015.05.007. Epub 2015 May 23.

  PMID: 26008873 BACKGROUND

• Ganesan M, Sathyaprabha TN, Gupta A, Pal PK. Effect of partial weight-supported treadmill gait training on balance in patients with Parkinson disease. PM R. 2014 Jan;6(1):22-33. doi: 10.1016/j.pmrj.2013.08.604. Epub 2013 Sep 8.

  PMID: 24021298 BACKGROUND

• Terson de Paleville D, McKay W, Aslan S, Folz R, Sayenko D, Ovechkin A. Locomotor step training with body weight support improves respiratory motor function in individuals with chronic spinal cord injury. Respir Physiol Neurobiol. 2013 Dec 1;189(3):491-7. doi: 10.1016/j.resp.2013.08.018. Epub 2013 Aug 31.

  PMID: 23999001 BACKGROUND

• Willoughby KL, Dodd KJ, Shields N, Foley S. Efficacy of partial body weight-supported treadmill training compared with overground walking practice for children with cerebral palsy: a randomized controlled trial. Arch Phys Med Rehabil. 2010 Mar;91(3):333-9. doi: 10.1016/j.apmr.2009.10.029.

  PMID: 20298820 BACKGROUND

• Mattern-Baxter K. Effects of partial body weight supported treadmill training on children with cerebral palsy. Pediatr Phys Ther. 2009 Spring;21(1):12-22. doi: 10.1097/PEP.0b013e318196ef42.

  PMID: 19214072 BACKGROUND

• Cherng RJ, Liu CF, Lau TW, Hong RB. Effect of treadmill training with body weight support on gait and gross motor function in children with spastic cerebral palsy. Am J Phys Med Rehabil. 2007 Jul;86(7):548-55. doi: 10.1097/PHM.0b013e31806dc302.

  PMID: 17581289 BACKGROUND

• Damiano DL, DeJong SL. A systematic review of the effectiveness of treadmill training and body weight support in pediatric rehabilitation. J Neurol Phys Ther. 2009 Mar;33(1):27-44. doi: 10.1097/NPT.0b013e31819800e2.

  PMID: 19265768 BACKGROUND

• Aras B, Yasar E, Kesikburun S, Turker D, Tok F, Yilmaz B. Comparison of the effectiveness of partial body weight-supported treadmill exercises, robotic-assisted treadmill exercises, and anti-gravity treadmill exercises in spastic cerebral palsy. Turk J Phys Med Rehabil. 2019 Nov 22;65(4):361-370. doi: 10.5606/tftrd.2019.3078. eCollection 2019 Jun.

  PMID: 31893273 BACKGROUND

• Flores MB, Da Silva CP. Trunk control and gross motor outcomes after body weight supported treadmill training in young children with severe cerebral palsy: a non-experimental case series. Dev Neurorehabil. 2019 Oct;22(7):499-503. doi: 10.1080/17518423.2018.1527862. Epub 2018 Oct 5.

  PMID: 30289316 BACKGROUND

• Sharan D, Rajkumar JS, Balakrishnan R, Kulkarni A, Selvakumar K, Gampa S, Mohandoss M, Ranganathan R. Effectiveness of a low-cost body weight support training device in the rehabilitation of cerebral palsy. J Rehabil Assist Technol Eng. 2016 Nov 29;3:2055668316676047. doi: 10.1177/2055668316676047. eCollection 2016 Jan-Dec.

  PMID: 31186916 BACKGROUND

• Su IY, Chung KK, Chow DH. Treadmill training with partial body weight support compared with conventional gait training for low-functioning children and adolescents with nonspastic cerebral palsy: a two-period crossover study. Prosthet Orthot Int. 2013 Dec;37(6):445-53. doi: 10.1177/0309364613476532. Epub 2013 Feb 22.

  PMID: 23436693 BACKGROUND

• Dodd KJ, Foley S. Partial body-weight-supported treadmill training can improve walking in children with cerebral palsy: a clinical controlled trial. Dev Med Child Neurol. 2007 Feb;49(2):101-5. doi: 10.1111/j.1469-8749.2007.00101.x.

  PMID: 17253995 BACKGROUND

• Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.

  PMID: 15137564 BACKGROUND

• Bertenthal B, Von Hofsten C. Eye, head and trunk control: the foundation for manual development. Neurosci Biobehav Rev. 1998 Jul;22(4):515-20. doi: 10.1016/s0149-7634(97)00038-9.

  PMID: 9595563 BACKGROUND

• Saavedra S, Karve SJ, Woollacott M, van Donkelaar P. Eye hand coordination in children with cerebral palsy. Exp Brain Res. 2009 Jan;192(2):155-65. doi: 10.1007/s00221-008-1549-8. Epub 2008 Oct 2.

  PMID: 18830589 BACKGROUND

• Saavedra S, Woollacott M, van Donkelaar P. Head stability during quiet sitting in children with cerebral palsy: effect of vision and trunk support. Exp Brain Res. 2010 Feb;201(1):13-23. doi: 10.1007/s00221-009-2001-4. Epub 2009 Sep 16.

  PMID: 19756550 BACKGROUND

• Verheyden G, Vereeck L, Truijen S, Troch M, Herregodts I, Lafosse C, Nieuwboer A, De Weerdt W. Trunk performance after stroke and the relationship with balance, gait and functional ability. Clin Rehabil. 2006 May;20(5):451-8. doi: 10.1191/0269215505cr955oa.

  PMID: 16774097 BACKGROUND

• Verheyden G, Nieuwboer A, De Wit L, Feys H, Schuback B, Baert I, Jenni W, Schupp W, Thijs V, De Weerdt W. Trunk performance after stroke: an eye catching predictor of functional outcome. J Neurol Neurosurg Psychiatry. 2007 Jul;78(7):694-8. doi: 10.1136/jnnp.2006.101642. Epub 2006 Dec 18.

  PMID: 17178824 BACKGROUND

• Hadders-Algra M & Brogren E. Postural control: A key issue in developmental disorders (1st ed.). London: MacKeith Press; 2008.

  BACKGROUND

• Prosser LA, Lee SC, VanSant AF, Barbe MF, Lauer RT. Trunk and hip muscle activation patterns are different during walking in young children with and without cerebral palsy. Phys Ther. 2010 Jul;90(7):986-97. doi: 10.2522/ptj.20090161. Epub 2010 Apr 29.

  PMID: 20430948 BACKGROUND

• van der Heide JC, Fock JM, Otten B, Stremmelaar E, Hadders-Algra M. Kinematic characteristics of postural control during reaching in preterm children with cerebral palsy. Pediatr Res. 2005 Sep;58(3):586-93. doi: 10.1203/01.pdr.0000176834.47305.26.

  PMID: 16148078 BACKGROUND

• Assaiante C, Mallau S, Viel S, Jover M, Schmitz C. Development of postural control in healthy children: a functional approach. Neural Plast. 2005;12(2-3):109-18; discussion 263-72. doi: 10.1155/NP.2005.109.

  PMID: 16097479 BACKGROUND

• Summa A, Vannozzi G, Bergamini E, Iosa M, Morelli D, Cappozzo A. Multilevel Upper Body Movement Control during Gait in Children with Cerebral Palsy. PLoS One. 2016 Mar 21;11(3):e0151792. doi: 10.1371/journal.pone.0151792. eCollection 2016.

  PMID: 26999362 BACKGROUND

• Punt M, Bruijn SM, Wittink H, van Dieen JH. Effect of arm swing strategy on local dynamic stability of human gait. Gait Posture. 2015 Feb;41(2):504-9. doi: 10.1016/j.gaitpost.2014.12.002. Epub 2014 Dec 26.

  PMID: 25582804 BACKGROUND

• Meyns P, Desloovere K, Van Gestel L, Massaad F, Smits-Engelsman B, Duysens J. Altered arm posture in children with cerebral palsy is related to instability during walking. Eur J Paediatr Neurol. 2012 Sep;16(5):528-35. doi: 10.1016/j.ejpn.2012.01.011. Epub 2012 Feb 14.

  PMID: 22336190 BACKGROUND

• Delabastita T, Desloovere K, Meyns P. Restricted Arm Swing Affects Gait Stability and Increased Walking Speed Alters Trunk Movements in Children with Cerebral Palsy. Front Hum Neurosci. 2016 Jul 15;10:354. doi: 10.3389/fnhum.2016.00354. eCollection 2016.

  PMID: 27471457 BACKGROUND

• Hussein, Z. A., Abd-Elwahab, M. S., & El-Shennawy, S. A. (2014). Effect of arm cycling on gait of children with hemiplegic cerebral palsy. Egyptian Journal of Medical Human Genetics, 15(3), 273-279. doi:10.1016/j.ejmhg.2014.02.008

  BACKGROUND

• Lee DH, Park SH, Han JW. Effect of bilateral upper extremity exercise on trunk performance in patients with stroke. J Phys Ther Sci. 2017 Apr;29(4):625-628. doi: 10.1589/jpts.29.625. Epub 2017 Apr 20.

  PMID: 28533598 BACKGROUND

• Awad A, Shaker H, Shendy W, Fahmy M. Effect of shoulder girdle strengthening on trunk alignment in patients with stroke. J Phys Ther Sci. 2015 Jul;27(7):2195-200. doi: 10.1589/jpts.27.2195. Epub 2015 Jul 22.

  PMID: 26311953 BACKGROUND

• Auble TE, Schwartz L, Robertson RJ. Aerobic Requirements for Moving Handweights Through Various Ranges of Motion While Walking. Phys Sportsmed. 1987 Jun;15(6):133-40. doi: 10.1080/00913847.1987.11709378.

  PMID: 27404531 BACKGROUND

• Owens SG, al-Ahmed A, Moffatt RJ. Physiological effects of walking and running with hand-held weights. J Sports Med Phys Fitness. 1989 Dec;29(4):384-7.

  PMID: 2628637 BACKGROUND

• Graves JE, Pollock ML, Montain SJ, Jackson AS, O'Keefe JM. The effect of hand-held weights on the physiological responses to walking exercise. Med Sci Sports Exerc. 1987 Jun;19(3):260-5.

  PMID: 3600240 BACKGROUND

• Swe NN, Sendhilnnathan S, van Den Berg M, Barr C. Over ground walking and body weight supported walking improve mobility equally in cerebral palsy: a randomised controlled trial. Clin Rehabil. 2015 Nov;29(11):1108-16. doi: 10.1177/0269215514566249. Epub 2015 Jan 30.

  PMID: 25636992 BACKGROUND

• Fedrizzi E, Facchin P, Marzaroli M, Pagliano E, Botteon G, Percivalle L, Fazzi E. Predictors of independent walking in children with spastic diplegia. J Child Neurol. 2000 Apr;15(4):228-34. doi: 10.1177/088307380001500405.

  PMID: 10805188 BACKGROUND

• Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.

  PMID: 9183258 BACKGROUND

• Elbasatiny, H., & Abdelaziem, A. (2015). Effect of Trunk Exercises on Trunk control, Balance and Mobility Function in Children with Hemiparetic Cerebral Palsy. International Journal of Therapies and Rehabilitation Research, 4(5), 236. doi:10.5455/ijtrr.00000094

  BACKGROUND

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 BACKGROUND

• Demura, S., Yamaji, S., Kitabayashi, T., Yamada, T., & Uchiyama, M. (2007). Effects of the package holding with one hand on the center of foot pressure. Sport Sciences for Health, 2(2), 58-63. doi:10.1007/s11332-007-0040-4

  BACKGROUND

• Ibrahim AI, Alhusaini AA, Hegazy FA, Hawamdeh ZM. Effectiveness of foot wedge and carrying weighted bag on loading the paretic lower limb in children with hemiparetic cerebral palsy. NeuroRehabilitation. 2013;32(3):563-71. doi: 10.3233/NRE-130878.

  PMID: 23648610 BACKGROUND

• Meyer-Heim A, Borggraefe I, Ammann-Reiffer C, Berweck S, Sennhauser FH, Colombo G, Knecht B, Heinen F. Feasibility of robotic-assisted locomotor training in children with central gait impairment. Dev Med Child Neurol. 2007 Dec;49(12):900-6. doi: 10.1111/j.1469-8749.2007.00900.x.

  PMID: 18039236 BACKGROUND

• Pirpiris M, Wilkinson AJ, Rodda J, Nguyen TC, Baker RJ, Nattrass GR, Graham HK. Walking speed in children and young adults with neuromuscular disease: comparison between two assessment methods. J Pediatr Orthop. 2003 May-Jun;23(3):302-7.

  PMID: 12724591 BACKGROUND

• Chrysagis N, Skordilis EK, Koutsouki D. Validity and clinical utility of functional assessments in children with cerebral palsy. Arch Phys Med Rehabil. 2014 Feb;95(2):369-74. doi: 10.1016/j.apmr.2013.10.025. Epub 2013 Nov 12.

  PMID: 24239880 BACKGROUND

• Pham HP, Eidem A, Hansen G, Nyquist A, Vik T, Saether R. Validity and Responsiveness of the Trunk Impairment Scale and Trunk Control Measurement Scale in Young Individuals with Cerebral Palsy. Phys Occup Ther Pediatr. 2016 Nov;36(4):440-52. doi: 10.3109/01942638.2015.1127867. Epub 2016 Feb 18.

  PMID: 26890372 BACKGROUND

• Marsico P, Mitteregger E, Balzer J, van Hedel HJA. The Trunk Control Measurement Scale: reliability and discriminative validity in children and young people with neuromotor disorders. Dev Med Child Neurol. 2017 Jul;59(7):706-712. doi: 10.1111/dmcn.13425. Epub 2017 Apr 4.

  PMID: 28374541 BACKGROUND

• Alkhajeh A, Arumugam A, Abd ElKafy E, Hegazy F. The effect of upper limb loading with external weights on gait and trunk control in ambulatory children with spastic hemiplegic cerebral palsy: a randomized controlled trial. Eur Rev Med Pharmacol Sci. 2024 Mar;28(6):2117-2126. doi: 10.26355/eurrev_202403_35715.

  PMID: 38567574 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Fatma Hegazy

  UOS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate Student

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: July 5, 2022
• Study Start: July 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)