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

NCT05032716 | Completed

• 1 other identifier: P.T.REC/ 012/001956
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Outcome Measures

Primary Outcomes (7)

• Step/Quick Turn (SQT)

  Turn Time (sec) from right and left side

  2 months

• Step/Quick Turn

  Turn Sway (deg/sec) from right and left side

  2 months

• Tandem Walk (TW)

  to measure Speed (cm/sec)

  2 months

• Tandem Walk (TW)

  to measure End Sway (deg/sec)

  2 months

• Overall Stability Index

  from Biodex Balance System

  2 months

• Antero-posterior Stability Index

  from Biodex Balance System

  2 months

• Medio-lateral Stability Index

  from Biodex Balance System

  2 months

Study Arms (2)

Balance exersices group

ACTIVE COMPARATOR

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

Other: Balance exrcises

Balance exersices and treadmill group

ACTIVE COMPARATOR

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)

Other: Balance exrcises and Treadmill training

Interventions

Balance exrcises 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 group

Balance exrcises and Treadmill training 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.

Balance exersices and treadmill group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Physical Therapy, Cairo University

Giza, Cairo Governorate, 12111, Egypt

Location

Faculty of Physical Therapy

Giza, Egypt

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Reham Alsakhawi, Ph.D

  Assistant Professor, Faculty of Physical Therapy, Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 2, 2021
• Study Start: May 5, 2021
• Primary Completion: July 10, 2021
• Study Completion: August 21, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months after study completion
• Access Criteria: data access requests will be reviewed by an external independent review panel. requestor will be required to sign a data access agreement

Locations

EG (2)