Playful Sensorimotor Training in Pediatric Brain Tumor Patients

NCT03334162 | Suspended DMC

• 1 other identifier: RESET-study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 children's 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 (N=20) 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 children's social reintegration.

Conditions

Pediatric Cancer; Pediatric Brain Tumor; Chemotherapy-induced Peripheral Neuropathy; Sensorimotor Polyneuropathy

Keywords

Children; Adolescents; Cancer; brain Tumor; exercise; Chemotherapy-induced Peripheral Neuropathy; CIPN; Sensorimotor Training

Outcome Measures

Primary Outcomes (1)

• Ped-mTNS score (assesses the change in the severity of CIPN symptoms)

  The Ped-mTNS Score comprises the patient reported outcome, in accordance with pharmaceutical studies to reduce the symptoms of CIPN as well as an objective clinical test battery, resulting in an overall score. The questionnaire contains questions regarding sensory, functional and autonomic symptoms of CIPN and will be used to document and assess the severity of the subjective peripheral neuropathy (PNP) symptoms. The clinical test battery contains light touch sensation, evaluated with Semmes-Weinstein-monofilaments, pin sensibility (MediPin), vibration sensibility assessed with a biothesiometer, deep tendon reflexes of Achilles and patellar tendons and muscular strength examined by a manual muscle test.

  Delta of Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).

Secondary Outcomes (9)

• short clinical test battery for CIPN

  Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).

• Postural control

  Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).

• Dorsiflexion function

  Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).

• Knee extension strength

  Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).

• lower limb power

  Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Sensorimotor training

Control group

NO INTERVENTION

Children in the control group will receive treatment as usual. The control group will be given the opportunity to participate in the intervention after study completion

Interventions

Sensorimotor training BEHAVIORAL

Supervised training sessions will last for about 20 to 30 minutes in total, including a child-specific warm-up and cool-down. The children will be asked to maintain balance in a previously acquired "short-foot-position", knees slightly flexed (30°), without shoes. Training will consist of 5 playful balance exercises, chosen from a standardized pool of exercises according to the child's age, with increasing difficulty (5 degrees of difficulty - e.g. by reducing the base of support, or dual task exercises - per exercise depending on the age group) in order to allow for individual, optimal progression. Each of the 5 exercises will contain of 5 repetitions for 10sec. allowing for a 20sec. rest in between each set and a 1min rest between each exercise in order to avoid neural fatigue. Children will be given a training manual and diary to train at home after the study. Guardians will be instructed in order to be able to assist their children

Also known as: There are no other intervention names.

Intervention group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients with a central nervous system (CNS) tumor
• age: ≥ 6 and ≤ 18 years
• neurotoxic chemotherapy treatment is completed 3 months to 2 years ago
• neurotoxic chemotherapy comprised a platinum-derivate or vinca-alkaloid (low grade gliomas: vincristine/carboplatin or vinblastin mono and embryonal tumors as well as ependymomas: cisplatin/ lomustine and vincristine or cyclophosphamide/ carboplatin/ vincristine/ etoposide)

You may not qualify if:

• neuropathies of other cause (e.g. diabetes)
• disabilities
• lack of German language that prevent the understanding of the informed consent as well as the instructions for training

Sponsors & Collaborators

• University of Basel: lead
• Kantonsspital Aarau: collaborator

Study Sites (1)

Kantonspital Aarau

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Fiona Streckmann

  University of Basel, Departement of Sport, Exercise and Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators dealing with the assessments (neurological and sport scientific) and data are blinded, solely the patient as well as the training staff can't be blinded due to the nature of an exercise interventional study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This pilot study will follow a prospective, two-armed, randomized controlled design (RCT with follow-up)

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 7, 2017
• Study Start: May 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)