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

30. Juni 2022 aktualisiert von: Alya Abdelghafour Alkhajeh

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.

Studienübersicht

Status

Anmeldung auf Einladung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

4 Jahre bis 8 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Upper Limb Loading Group
Partial body weight support treadmill training with upper limb external weights in addition to conventional treatment: balance, gait training, facilitation for normal development
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.
Kein Eingriff: Control Group
Partial body weight support treadmill training without upper limb external weights in addition to conventional treatment: balance, gait training, facilitation for normal development

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline 10-meters walk test at 6 weeks
Zeitfenster: At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)
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
Zeitfenster: At the baseline (before treatment starts) and 6 weeks (at the end of the treatment)

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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Fatma Hegazy, UOS

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. Juli 2022

Primärer Abschluss (Voraussichtlich)

1. September 2022

Studienabschluss (Voraussichtlich)

1. Oktober 2022

Studienanmeldedaten

Zuerst eingereicht

19. Juni 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Juni 2022

Zuerst gepostet (Tatsächlich)

5. Juli 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juli 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Juni 2022

Zuletzt verifiziert

1. Juni 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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