Acute Lymphoblastic Leukemia, PediatricNCT05032716
EFFECT OF TREADMILL TRAINING ON BALANCE AFTER CHEMOTHERAPY IN CHILDREN WITH ACUTE LYMPHOBLASTIC LEUKEMIA
A study testing Balance exrcises and Balance exrcises and Treadmill training in people with Acute Lymphoblastic Leukemia, Pediatric, run by Cairo University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Pediatric
- What is being tested?
- Balance exrcises and Balance exrcises and Treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 May 2021to 21 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- able to recognize commands given to them,
- understand our verbal command and encouragement,
- and stand and walk independently without repeated falling
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Physical Therapy, Cairo University
Giza, Cairo Governorate, 12111
Faculty of Physical Therapy
Giza
About this study
Official title: Treadmill Training is an Effective Rehabilitation Program in Treatment of 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.
Read the 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
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Being tested
- Balance exrcises, Balance exrcises and Treadmill training
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance exrcisesOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Other: Balance exrcises and Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step/Quick Turn (SQT)
Turn Time (sec) from right and left side
Measured: 2 months
Step/Quick Turn
Turn Sway (deg/sec) from right and left side
Measured: 2 months
Tandem Walk (TW)
to measure Speed (cm/sec)
Measured: 2 months
Tandem Walk (TW)
to measure End Sway (deg/sec)
Measured: 2 months
Overall Stability Index
from Biodex Balance System
Measured: 2 months
Antero-posterior Stability Index
from Biodex Balance System
Measured: 2 months
Medio-lateral Stability Index
from Biodex Balance System
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start5 May 2021
- Primary completion10 Jul 2021
- Study completion21 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic Leukemia, PediatricStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Saeed Alsakhawi, Cairo University
- Investigators
- Reham Alsakhawi, Ph.D, Principal investigator, Assistant Professor, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032716
- Sponsor's protocol ID
- P.T.REC/ 012/001956
- Status last verified
- Nov 2021
- First submitted
- 31 Aug 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data from participants will be made available
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treadmill Training is an Effective Rehabilitation Program in Treatment of Children With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05032716
- Acronym / sponsor ID
- P.T.REC/ 012/001956
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 21 Aug 2021 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance exersices group | Active comparator | Other: Balance exrcisesreceived traditional exercise program with instructions given to the children for 60 min aiming to improve posture control and balance |
| Balance exersices and treadmill group | Active comparator | Other: Balance exrcises and Treadmill trainingreceived the same traditional physical therapy program as the same applied in group of balance exercise (30 min), in addition to treadmill training (30 min) |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- able to recognize commands given to them,
- understand our verbal command and encouragement,
- and stand and walk independently without repeated falling
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance exrcisesthe 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 | Other | Balance exersices group |
| Balance exrcises and Treadmill trainingthe 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. | Other | Balance exersices and treadmill group |
Primary outcome
Step/Quick Turn (SQT)
Time frame: 2 months
Turn Time (sec) from right and left side
Step/Quick Turn
Time frame: 2 months
Turn Sway (deg/sec) from right and left side
Tandem Walk (TW)
Time frame: 2 months
to measure Speed (cm/sec)
Tandem Walk (TW)
Time frame: 2 months
to measure End Sway (deg/sec)
Overall Stability Index
Time frame: 2 months
from Biodex Balance System
Antero-posterior Stability Index
Time frame: 2 months
from Biodex Balance System
Medio-lateral Stability Index
Time frame: 2 months
from Biodex Balance System
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: Yes. data from participants will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reham Alsakhawi, Ph.D principal investigator
Assistant Professor, Faculty of Physical Therapy, Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance exrcises and Balance exrcises and Treadmill training in people with Acute Lymphoblastic Leukemia, Pediatric, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step/Quick Turn (SQT) (time frame: 2 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.