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The ASsessment and Physiotherapy managEment of Ataxia in Children Following Surgical Resection of Posterior Fossa Tumour (ASPECT)

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ClinicalTrials.gov Identifier: NCT03945682
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Alder Hey Children's NHS Foundation Trust

Brief Summary:
The overall aim of the study is to determine the feasibility of conducting a randomised controlled trial (RCT) studying the effectiveness of physiotherapy intervention (virtual training) in children with ataxia following surgical resection of posterior fossa tumour

Condition or disease Intervention/treatment Phase
Ataxia Posterior Fossa Tumor Other: Therapist Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomised to one of 2 groups 1. Intervention arm 2. Usual standard of care.
Masking: None (Open Label)
Masking Description: No study drug as part of this RCT
Primary Purpose: Treatment
Official Title: The ASsessment and Physiotherapy managEment of Ataxia in Children Following Surgical Resection of Posterior Fossa Tumour (ASPECT)
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: Therapist
Intervention therapist at 2 centres providing 8 week intervention programme 50% embedded qualitative study
Other: Therapist
Intervention therapist at 2 centres providing 8 week intervention programme 50% embedded qualitative study

No Intervention: Usual Standard of Care
Participants continue with usual care and existing therapy recorded in study diary



Primary Outcome Measures :
  1. Process Measures [ Time Frame: 32 months ]
    Number of patients identified who meet the inclusion criteria and are then subsequently recruited will be recorded.

  2. Intervention Process Measures [ Time Frame: 32 months ]
    Number of patients who complete all sessions of the intervention will be recorded and the patient's adherence to treatment in the home setting will be noted.


Secondary Outcome Measures :
  1. SARA [ Time Frame: 32 months ]
    Scale for the Assessment and Rating of Ataxia

  2. BARS [ Time Frame: 32 months ]
    Brief Ataxia Rating Scale

  3. 9HPT [ Time Frame: 32 months ]
    Nine hole peg test

  4. PEDI [ Time Frame: 32 months ]
    Paediatric Evaluation of Disability Index

  5. PedsQL [ Time Frame: 32 months ]
    Brain Tumour Module

  6. BBS [ Time Frame: 32 months ]
    Berg Balance Scale

  7. INAS [ Time Frame: 32 months ]
    Inventory of Non Ataxia Signs. Assessment of compliance (diary)

  8. Subjective Impact [ Time Frame: 32 months ]
    Subjective Impact Likert Scale



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child or young person (4-<18 years) demonstrating ataxia. (For this study, ataxia is currently defined as SARA greater than 2. This definition is taken from data from the CARS study to date, from the cut off threshold value distinguishing no ataxia from mild ataxia)
  • 12 months to 3 years following surgical resection of posterior fossa tumour. (This time frame has been selected as this covers the time when the children will typically have completed any adjunct oncology treatment and therefore more emphasis is dedicated to rehabilitation).

Exclusion Criteria:

  • Medically unstable/currently undergoing adjunctive treatment e.g. radiotherapy or chemotherapy
  • Less than 4 years of age (due to inability to complete standardized assessments)
  • Aged 18 or over
  • Unable to stand independently for less than one minute or SARA gait item score over 4, either of which would inhibit capacity to complete the training session.
  • Presence of co-morbities with the potential to affect the safety of training, such as congenital or acquired disorders causing high risk of falls or lack of comprehension of training tasks, or current musculoskeletal impairments (such as a non-union fracture or fracture currently healing limiting weight-bearing)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945682


Contacts
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Contact: Helen Hartley 0151 252 5660 helen.hartley@alderhey.nhs.uk
Contact: Research Alder Hey 0151 252 5570 research@alderhey.nhs.uk

Locations
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United Kingdom
Alder Hey Children's NHS Foundation Trust Recruiting
Liverpool, Merseyside, United Kingdom, L12 2AP
Contact: Research Alder Hey    0151 252 5570    research@alderhey.nhs.uk   
Sponsors and Collaborators
Alder Hey Children's NHS Foundation Trust

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Responsible Party: Alder Hey Children's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03945682     History of Changes
Other Study ID Numbers: 227917
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alder Hey Children's NHS Foundation Trust:
physiotherapy
surgical resection
Additional relevant MeSH terms:
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Infratentorial Neoplasms
Ataxia
Cerebellar Ataxia
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms