EFFECT OF TREADMILL TRAINING ON BALANCE AFTER CHEMOTHERAPY IN CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA
Primary Purpose
Acute Lymphoblastic Leukemia, Pediatric
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Balance exrcises
Balance exrcises and Treadmill training
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia, Pediatric
Eligibility Criteria
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
Sites / Locations
- Faculty of Physical Therapy, Cairo University
- Faculty of Physical Therapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Balance exersices group
Balance exersices and treadmill group
Arm Description
received traditional exercise program with instructions given to the children for 60 min aiming to improve posture control and balance
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)
Outcomes
Primary Outcome Measures
Step/Quick Turn (SQT)
Turn Time (sec) from right and left side
Step/Quick Turn
Turn Sway (deg/sec) from right and left side
Tandem Walk (TW)
to measure Speed (cm/sec)
Tandem Walk (TW)
to measure End Sway (deg/sec)
Overall Stability Index
from Biodex Balance System
Antero-posterior Stability Index
from Biodex Balance System
Medio-lateral Stability Index
from Biodex Balance System
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05032716
Brief Title
EFFECT OF TREADMILL TRAINING ON BALANCE AFTER CHEMOTHERAPY IN CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA
Official Title
Treadmill Training is an Effective Rehabilitation Program in Treatment of Children With Acute Lymphoblastic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
July 10, 2021 (Actual)
Study Completion Date
August 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, Pediatric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balance exersices group
Arm Type
Active Comparator
Arm Description
received traditional exercise program with instructions given to the children for 60 min aiming to improve posture control and balance
Arm Title
Balance exersices and treadmill group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Balance exrcises
Intervention Description
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
Intervention Name(s)
Balance exrcises and Treadmill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Step/Quick Turn (SQT)
Description
Turn Time (sec) from right and left side
Time Frame
2 months
Title
Step/Quick Turn
Description
Turn Sway (deg/sec) from right and left side
Time Frame
2 months
Title
Tandem Walk (TW)
Description
to measure Speed (cm/sec)
Time Frame
2 months
Title
Tandem Walk (TW)
Description
to measure End Sway (deg/sec)
Time Frame
2 months
Title
Overall Stability Index
Description
from Biodex Balance System
Time Frame
2 months
Title
Antero-posterior Stability Index
Description
from Biodex Balance System
Time Frame
2 months
Title
Medio-lateral Stability Index
Description
from Biodex Balance System
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reham Alsakhawi, Ph.D
Organizational Affiliation
Assistant Professor, Faculty of Physical Therapy, Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy, Cairo University
City
Giza
State/Province
Cairo
ZIP/Postal Code
12111
Country
Egypt
Facility Name
Faculty of Physical Therapy
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
data from participants will be made available
IPD Sharing Time Frame
6 months after study completion
IPD Sharing Access Criteria
data access requests will be reviewed by an external independent review panel. requestor will be required to sign a data access agreement
Learn more about this trial
EFFECT OF TREADMILL TRAINING ON BALANCE AFTER CHEMOTHERAPY IN CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA
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