Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05125666

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effect of using a selected dual-task- training program to improve postural stability in children with ataxia after medulloblastoma resection. Thirty patients will participate in this study. Patients will be classified randomly into two equal groups: study and control groups -Both groups will receive conventional physical therapy treatment including mobility exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning. In addition, the study group will receive a selected dual-task training program including balance and cognitive activities. The treatment program will be conducted three days per week for eight successive weeks. The patients will be assessed with the Scale of Assessment and Rating of Ataxia, Humac Balance System, the Pediatric Balance Scale and Functional Independent Measurement. The measures will be recorded two times: before the application of the treatment program (pre) and after the end of the treatment program (post).

Condition or Disease	Intervention/Treatment	Phase
Ataxia Medulloblastoma	Other: Dual Task Training (Motor + Cognitive) Other: Traditional Regular Exercise	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Dual Task Training on Children With Ataxia After Medulloblastoma Resection: (A Randomized Controlled Trial)

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual Task Training	Other: Dual Task Training (Motor + Cognitive) Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the traditional physical therapy program three times weekly for 8 successive weeks.
Active Comparator: Ordinary Physical Therapy for Ataxia	Other: Traditional Regular Exercise Each child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks.

Arm

Intervention/Treatment

Experimental: Dual Task Training

Other: Dual Task Training (Motor + Cognitive)

Each child in this group will perform one-hour session consist of two tasks (cognitive and balance task) in addition to the traditional physical therapy program three times weekly for 8 successive weeks.

Active Comparator: Ordinary Physical Therapy for Ataxia

Other: Traditional Regular Exercise

Each child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks.

Outcome Measures

Primary Outcome Measures

Improvement in Static balance of patients with ataxia after resection measured by center of pressure using force plate mode in the humac balance system. [2 months]
Improvement in dynamic balance of patients with ataxia after resection measured by using tilt mode in the humac balance system. [2 months]
Improvement in Activities of Daily Living (ADL) measured by functional independence measurement. [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All children with the following criteria will be in rolled in the study

Age range from (5-10 years).
Severity of ataxia will be from 15-30 by SARA scale.
Children after 2 months of medulloblastoma resection.
They can stand and walk with minimal support.
They have good cognition, compliance, and ability to understand and instructions.
Children receiving radiotherapy and chemotherapy sessions
They are medically stable

Exclusion Criteria:

Children will be excluded from the study if they have

Any neuromuscular disorder.
Visual impairment.
Cognitive problem
Convulsion.
Peripheral neuropathy due to chemotherapy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	57357 Children Cancer Hospital	Cairo	El Sayeda Zainab	Egypt

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fatma Mostafa Sedeek Selim, Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05125666

Other Study ID Numbers:

DTT-Ataxia-1

First Posted:

Nov 18, 2021

Last Update Posted:

Nov 18, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Medulloblastoma

Ataxia

Cerebellar Ataxia

Study Results

No Results Posted as of Nov 18, 2021