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Cerebral PalsyNCT05444387

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

A study testing Upper limb loading in people with Cerebral Palsy, run by Alya Abdelghafour Alkhajeh at 1 site in United Arab Emirates.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 8 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Upper limb loading
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Arab Emirates
Study dates
1 Jul 2022to 1 Oct 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 4 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site
  • Al Qassimi Women's and Children's Hospital

    Sharjah city

Other trials in United Arab Emirates

About this study

Official title: The Effect of Upper Limb Loading With External Weights During Partial Body Weight Support Treadmill Training on Gait and Trunk Control in Ambulatory Children With Cerebral Palsy: A Randomized Controlled Trial

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.

Read the detailed description

Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder which affects the child's motor and sensory system, and consequently posture and walking. The underlying etiology is considered multifactorial, and no specific etiological factor has been blamed. While it may be seen in the prenatal, neonatal, and postnatal period, prenatal factors account for 70 to 80 % of all cases. Although the incidence of cerebral palsy widely varies worldwide, it has been often estimated as 1.5 to 2.5/1000. While the prevalence in young people is as high as 74%. One of the characteristics of CP is gait abnormalities because of myasthenia, spasticity and impairment of movement. Children with CP have difficulties in activities, which severely affect the children's quality of life. There is no cure for CP. WHO considers limb movement function as the main rehabilitation goal. Walking capacity training of CP needs to be taken seriously. Physiotherapy is considered the core part of CP children rehabilitation due to the risk of neurosurgery and side effects of drug intervention.

Many of the gait deviations observed in neurologically impaired patient results from their inability to adequately bear weight through their affected lower extremities during the loading phase of the gait cycle. Treadmill walking with partial body weight support (PBWS) using a harness seems to address the problem. It allows even a patient with severe weakness of lower limb extensor muscles to go through the gait cycle because lower levels of muscle forces are needed to support the body mass compared with over ground walking. In addition, the harness provides a sense of secure to the patient who has fear of falling.

Partial body weight support (PBWS) systems have been widely used as an alternative therapeutic strategy for gait training in different populations, including individuals with stroke , Parkinson's disease , Spinal cord injury and children with cerebral palsy.

Some individual studies suggested that treadmill training with body weight support was superior to treadmill training alone. The addition of body weight support makes repetitive training far more feasible for a boarder range of clients and allows for more flexibility in terms of optimizing speed and training kinematic patterns for those with weakness of other impairments limiting their gait function by increasing safety and decreasing the physical work necessary by one of more therapists. Many studies showed the effectiveness of body weight support training on gait and gross motor function in the rehabilitation of CP.

The trunk plays a critical role in the organization of postural reaction. The primary contribution of the trunk muscles is to stabilize the spine and trunk, and this stabilization is essential for free and selective movements of the head and the extremities. Children with CP frequently show impaired trunk control, which can affect performance of activities of daily life such as sitting, reaching and walking. The trunk was described as a key segment in the organization of postural stabilization and orientation control.

Upper body movement during walking provide information about balance control and gait stability, and children with CP exhibit a general increase of upper body acceleration compared to typically developing (TD) children which present a progressive decrease of acceleration from pelvis to head. Also, it has been found that excessive arm swing significantly increases local dynamics stability of human gait. And children with CP appear to rely on 'guard' arm posture as a compensation strategy to maintain balance while walking compared to newly walking toddlers. Spasticity and associated movements are also important contributing factors. The hand position of children with unilateral CP has been found to be more elevated and anterior, and their upper arm was rotated more posterior than typically developing children. A study showed that facilitation of arm swing in specific situations possibly enhances safety and reduces the risk of falling in children with CP. Using arm cycling exercise has been found as an effective method for improving both arm swing and leg angular displacements during gait of children with hemiplegic CP. Also, it has been found that bilateral upper extremity exercises has a positive effect on trunk performance and alignment in stroke patients. From all of this physiotherapists get to know the importance of involving the upper limbs in the rehabilitation program for children with CP to improve gait.

A study indicated that walking while moving hand weights through large range of motion provides a combined upper and lower body aerobic stimulus that is sufficient for endurance training for persons with poor to excellent levels of aerobic fitness. Other studies looked for the physiological effect of hand-held weights during walking in normal adults. However, according to our knowledge no studies looked for the effect of upper limb external weights on gait and trunk in children with cerebral palsy. The investigators expect that placing an external weight around the both wrists while walking on the treadmill with partial body weight support will improve trunk control and gait in ambulatory children with cerebral palsy. The purpose of this study is to investigate if adding upper limb external weights during gait training using PBWS can increase the walking endurance, speed and trunk control in ambulatory children with CP.

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.

Trial Design:

Randomized control trial

Conditions
Cerebral Palsy
Being tested
Upper limb loading
Medical subject headings
Cerebral Palsy

What participants receive

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

  • Upper limb loadingOther

    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.

Study groups in NCT05444387
Study groupRoleWhat they receive
Upper Limb Loading GroupExperimentalPartial body weight support treadmill training with upper limb external weights in addition to conventional treatment: balance, gait training, facilitation for normal development
Receives: Other: Upper limb loading
Control GroupNo interventionPartial body weight support treadmill training without upper limb external weights in addition to conventional treatment: balance, gait training, facilitation for normal development

What is being measured

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

  1. 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.

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

  2. 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.

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

Timeline

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

  1. First posted5 Jul 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Oct 2022 (estimated)

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, Care provider
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444387
Sponsor's protocol ID
U19102427
Status last verified
Jun 2022
First submitted
19 Jun 2022
Last updated
5 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 12234229
  • 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.

    PubMed 17370477
  • 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.

    PubMed 17188824
  • 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.

    PubMed 30378122
  • 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.

    PubMed 30892974
  • 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.

    PubMed 28728959
  • 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.

    PubMed 27341370
  • 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.

    PubMed 25255910
  • 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.

    PubMed 27848255
  • 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.

    PubMed 24268104
  • 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.

    PubMed 29220616
  • Shepherd, R., & Carr, J. (1999). Treadmill Walking in Neurorehabilitation. Neurorehabilitation and Neural Repair, 13(3), 171-173. doi:10.1177/154596839901300303

  • 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.

    PubMed 22018267
  • 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.

    PubMed 21864373
  • 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.

    PubMed 11994808

Questions about this trial

What is this clinical trial studying?

A study testing Upper limb loading in people with Cerebral Palsy, run by Alya Abdelghafour Alkhajeh at 1 site in United Arab Emirates.

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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 United Arab Emirates. 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?

Results are not available in the source record.

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?

Change from Baseline 10-meters walk test at 6 weeks (time frame: At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)). 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 NCT05444387, which also lists 62 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 5 Jul 2022.

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