Clinical trial · Interventional
The ASsessment and Physiotherapy managEment of Ataxia in Children Following Surgical Resection of Posterior Fossa Tumour
The ASsessment and Physiotherapy managEment of Ataxia in Children Following Surgical Resection of Posterior Fossa Tumour (ASPECT)
NCT03945682CI-TRIAL-00038554ASPECTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ataxia | — | UNRESOLVED | — |
| Posterior Fossa Tumor | Posterior Fossa Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapist | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Therapist
- description
- Intervention therapist at 2 centres providing 8 week intervention programme 50% embedded qualitative study
- interventionNames
- Other: Therapist
- type
- NO_INTERVENTION
- label
- Usual Standard of Care
- description
- Participants continue with usual care and existing therapy recorded in study diary
Primary outcomes (2)
- measure
- Process Measures
- timeFrame
- 32 months
- description
- Number of patients identified who meet the inclusion criteria and are then subsequently recruited will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.