EFFECT OF TREADMILL TRAINING ON BALANCE AFTER CHEMOTHERAPY IN CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA

NCT ID: NCT05032716

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2021-08-21

Brief Summary

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Purpose: The present research was conducted to study the effect of treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia.

Subjects and Methods: Forty children with acute lymphoblastic leukemia included in the current research ranged of age from 8 to 12 years. The children participated in this study were assigned randomly into two equal number groups (A and B). Group (A) includes 20 children who received balance exercises, while group (B) includes 20 children who received the same balance exercises of group (A) and treadmill training. The treatment program was applied three sessions per week (60 min for every session) for 8 weeks. Balance Master System and Biodex Balance System were used to evaluate balance of all children in the three groups before and after the treatment program.

Detailed Description

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The current research is a randomized control trial to differentiate between the treadmill training on balance after chemotherapy in children with acute lymphoblastic leukemia. Chemotherapy induced peripheral neuropathy is related to the intensity of treatment and dosage of chemotherapy which could affect the severity of its symptoms, it could result in serious problems like sensory changes and numbness , in case the sensory nerves were affected , muscle weakness and in-coordination in case the affected were the motor nerves. In addition to the psychological problems the patient experience as a result of CIPN, the patient also experience physical problems like injuries, fear of fall results from lack of sensory perception and muscle power. Treadmill training, motor training may favor proprioceptive feedback, leading to adjustments for adequate postural balance and functional performance. Treadmill exercises stimulate the kinetic, kinematic, and temporal features of walking. These exercises improve the strength of the muscles of the lower extremities, enhance motor learning, improve functional abilities, and activate the locomotor control system

Conditions

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Acute Lymphoblastic Leukemia, Pediatric

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Balance exersices group

received traditional exercise program with instructions given to the children for 60 min aiming to improve posture control and balance

Group Type ACTIVE_COMPARATOR

Balance exrcises

Intervention Type OTHER

the group (20 children) received traditional exercise program with instructions given to the children for 60 min aiming to improve posture control and balance. Tools of traditional physical therapy exercises were; special tools were used for traditional physical therapy exercises include vestibular board, rolls of different sizes, blocks and wedges of different heights

Balance exersices and treadmill group

received the same traditional physical therapy program as the same applied in group of balance exercise (30 min), in addition to treadmill training (30 min)

Group Type ACTIVE_COMPARATOR

Balance exrcises and Treadmill training

Intervention Type OTHER

the group (20 children) received the same traditional physical therapy program as the same applied in group of balance exercises, in addition to treadmill training (30 min). The child walked on the treadmill (motorized treadmill, ENTRED, Enraf-Nonius) at 75% of over-ground speed and individually prescribed low-endurance walking at 0% incline for 20 min, three times a week for 8 successive weeks. The walking area of the treadmill is made from heavy steel with a minimum 8-inch thickness and is available with cushioning in case of accidental impacts. Before the walking session, each child underwent 5 min of active stretching exercises that include prolonged and progressive stretching of the hamstrings, quadriceps muscles, and Achilles tendon.

Interventions

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Balance exrcises

the group (20 children) received traditional exercise program with instructions given to the children for 60 min aiming to improve posture control and balance. Tools of traditional physical therapy exercises were; special tools were used for traditional physical therapy exercises include vestibular board, rolls of different sizes, blocks and wedges of different heights

Intervention Type OTHER

Balance exrcises and Treadmill training

the group (20 children) received the same traditional physical therapy program as the same applied in group of balance exercises, in addition to treadmill training (30 min). The child walked on the treadmill (motorized treadmill, ENTRED, Enraf-Nonius) at 75% of over-ground speed and individually prescribed low-endurance walking at 0% incline for 20 min, three times a week for 8 successive weeks. The walking area of the treadmill is made from heavy steel with a minimum 8-inch thickness and is available with cushioning in case of accidental impacts. Before the walking session, each child underwent 5 min of active stretching exercises that include prolonged and progressive stretching of the hamstrings, quadriceps muscles, and Achilles tendon.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* able to recognize commands given to them,
* understand our verbal command and encouragement,
* and stand and walk independently without repeated falling

Exclusion Criteria

* Children with impairment of sensation or
* other neurological or psychological problems,
* tightness and/or fixed deformity of lower limbs,
* any neurological, musculoskeletal, or mobility disorders,
* cardiac anomalies,
* vision or hearing loss
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Reham Saeed Alsakhawi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reham Alsakhawi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor, Faculty of Physical Therapy, Cairo University

Locations

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Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, Egypt

Site Status

Faculty of Physical Therapy

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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P.T.REC/ 012/001956

Identifier Type: -

Identifier Source: org_study_id