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

NCT03945682 | Unknown

• 1 other identifier: 227917
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Ataxia; Posterior Fossa Tumor

Keywords

physiotherapy; surgical resection

Outcome Measures

Primary Outcomes (2)

• Process Measures

  Number of patients identified who meet the inclusion criteria and are then subsequently recruited will be recorded.

  32 months

• Intervention Process Measures

  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.

  32 months

Secondary Outcomes (8)

• SARA

  32 months

• BARS

  32 months

• 9HPT

  32 months

• PEDI

  32 months

• PedsQL

  32 months

Study Arms (2)

Therapist

EXPERIMENTAL

Intervention therapist at 2 centres providing 8 week intervention programme 50% embedded qualitative study

Other: Therapist

Usual Standard of Care

NO INTERVENTION

Participants continue with usual care and existing therapy recorded in study diary

Interventions

Therapist OTHER

Intervention therapist at 2 centres providing 8 week intervention programme 50% embedded qualitative study

Therapist

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Alder Hey Children's NHS Foundation Trust: lead

Study Sites (1)

Alder Hey Children's NHS Foundation Trust

Liverpool, Merseyside, L12 2AP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ataxia; Infratentorial Neoplasms

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Helen Hartley

CONTACT

0151 252 5660; helen.hartley@alderhey.nhs.uk

Research Alder Hey

CONTACT

0151 252 5570; research@alderhey.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No study drug as part of this RCT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised to one of 2 groups 1. Intervention arm 2. Usual standard of care.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: March 5, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)