Ignite Creation Date:
2024-05-06 @ 10:42 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03334162
Status:
SUSPENDED
Last Update Posted:
2019-04-19
First Post:
2017-10-30
Brief Title:
Playful Sensorimotor Training in Pediatric Brain Tumor Patients
Sponsor:
University of Basel
Organization:
University of Basel
Study Overview
Official Title:
Playful Sensorimotor Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy in Pediatric Brain Tumor Patients- a Randomized Controlled Trial
Status:
SUSPENDED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study temporarily paused due to an Amendment request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESET
Brief Summary:
Chemotherapy-induced peripheral neuropathy CIPN is a highly prevalent and clinically relevant side-effect of cancer treatment The severe symptoms such as loss of sensation numbness pain absent reflexes or loss of balance control not only diminish childrens quality of life but also affect the medical therapy To date there are no effective treatment options to reduce the symptoms of CIPN Promising results have so far been achieved with specific exercise interventions
The investigators would therefore like to conduct a prospective multicenter two-armed trial RCT with follow-up Patients N20 will be recruited from the Hospital for Children and Adolescents Kantonsspital Aarau Prior to randomization all primarily eligible patients that have received a platin derivate or vinca-alkaloid will be screened for symptoms of CIPN Eligible patients with a neurologically confirmed CIPN will then be randomized either into an intervention group or a control group CG Patients in the intervention group will perform a standardized age-adjusted specific playful sensorimotor training SMT program twice a week for 12 weeks in addition to usual care while the control group receives treatment as usual The CG will be given the opportunity to participate in the intervention after study completion Data change will be assessed at 3 time points At baseline T0 after 12 weeks post intervention testing T1 and after 12 weeks of follow-up T2 Primary endpoint is the Ped-mTNS score in order to subjectively as well as objectively assess the severity of CIPN symptoms It contains a short questionnaire as well as more objective parameters such as light touch sensation pin sensibility vibration sensibility deep tendon reflexes and muscular strength Additionally the CIPN symptom pattern will be assessed via nerve conduction studies CIPN related pain dorsiflexion and knee extension as well as postural control Furthermore investigators will be evaluating patients level of physical activity walk to run transition time lower limb power as well as patients integration in physical education PE in school and sport club activities The investigators hypothesize that patients in the intervention group will be able to reduce relevant symptoms of CIPN improving related physical functions and enhancing childrens social reintegration
The investigators would therefore like to conduct a prospective multicenter two-armed trial RCT with follow-up Patients N20 will be recruited from the Hospital for Children and Adolescents Kantonsspital Aarau Prior to randomization all primarily eligible patients that have received a platin derivate or vinca-alkaloid will be screened for symptoms of CIPN Eligible patients with a neurologically confirmed CIPN will then be randomized either into an intervention group or a control group CG Patients in the intervention group will perform a standardized age-adjusted specific playful sensorimotor training SMT program twice a week for 12 weeks in addition to usual care while the control group receives treatment as usual The CG will be given the opportunity to participate in the intervention after study completion Data change will be assessed at 3 time points At baseline T0 after 12 weeks post intervention testing T1 and after 12 weeks of follow-up T2 Primary endpoint is the Ped-mTNS score in order to subjectively as well as objectively assess the severity of CIPN symptoms It contains a short questionnaire as well as more objective parameters such as light touch sensation pin sensibility vibration sensibility deep tendon reflexes and muscular strength Additionally the CIPN symptom pattern will be assessed via nerve conduction studies CIPN related pain dorsiflexion and knee extension as well as postural control Furthermore investigators will be evaluating patients level of physical activity walk to run transition time lower limb power as well as patients integration in physical education PE in school and sport club activities The investigators hypothesize that patients in the intervention group will be able to reduce relevant symptoms of CIPN improving related physical functions and enhancing childrens social reintegration
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None