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

Acute Lymphoblastic Leukemia, Pediatric Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032716
• Other study ID #: P.T.REC/ 012/001956
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: August 21, 2021

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 21, 2021
• Est. primary completion date: July 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Pediatric
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza
Egypt	Faculty of Physical Therapy, Cairo University	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step/Quick Turn (SQT)	Turn Time (sec) from right and left side	2 months
Primary	Step/Quick Turn	Turn Sway (deg/sec) from right and left side	2 months
Primary	Tandem Walk (TW)	to measure Speed (cm/sec)	2 months
Primary	Tandem Walk (TW)	to measure End Sway (deg/sec)	2 months
Primary	Overall Stability Index	from Biodex Balance System	2 months
Primary	Antero-posterior Stability Index	from Biodex Balance System	2 months
Primary	Medio-lateral Stability Index	from Biodex Balance System	2 months