Clinical trial NCT05032716: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia, Pediatric
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Step/Quick Turn (SQT)
timeFrame: 2 months
measure: Step/Quick Turn
timeFrame: 2 months
measure: Tandem Walk (TW)
timeFrame: 2 months
measure: Tandem Walk (TW)
timeFrame: 2 months
measure: Overall Stability Index
timeFrame: 2 months
measure: Antero-posterior Stability Index
timeFrame: 2 months
measure: Medio-lateral Stability Index
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy, Cairo University
state: Cairo
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Assistant Professor, Faculty of Physical Therapy, Cairo University
name: Reham Alsakhawi, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: