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Completed

NCT Number: NCT05032716

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

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Cairo University, Giza, Cairo Governorate, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. Step/Quick Turn (SQT)

    Time frame: 2 months

    Turn Time (sec) from right and left side

  2. Step/Quick Turn

    Time frame: 2 months

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

  3. Tandem Walk (TW)

    Time frame: 2 months

    to measure Speed (cm/sec)

  4. Tandem Walk (TW)

    Time frame: 2 months

    to measure End Sway (deg/sec)

  5. Overall Stability Index

    Time frame: 2 months

    from Biodex Balance System

  6. Antero-posterior Stability Index

    Time frame: 2 months

    from Biodex Balance System

  7. Medio-lateral Stability Index

    Time frame: 2 months

    from Biodex Balance System

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Treadmill Training is an Effective Rehabilitation Program in Treatment of Children With Acute Lymphoblastic Leukemia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 2, 2021
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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