Playful Sensorimotor Training in Pediatric Brain Tumor Patients

NCT ID: NCT03334162

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2020-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Sensorimotor training

Intervention Type: 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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sensorimotor training

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

Intervention Type: BEHAVIORAL

Other Intervention Names

There are no other intervention names.

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Aarau

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Dr. Fiona Streckmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona Streckmann

Role: PRINCIPAL_INVESTIGATOR

University of Basel, Departement of Sport, Exercise and Health

Locations

Kantonspital Aarau

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

RESET-study

Identifier Type: -

Identifier Source: org_study_id