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CTRI Number  CTRI/2024/10/075168 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 11/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Enhancing Balance and Gait Speed: Integrating PEDALS(Pediatric Endurance And Limb Strengthening Protocol with Conventional Physiotherapy in Children with Spastic Diplegic Cerebral Palsy 
Scientific Title of Study   Added Effect Of PEDALS (Pediatric Endurance and Limb Strengthening)Protocol Along With Conventional Physiotherapy On Balance And Gait Speed In Children With Spastic Diplegic Cerebral Palsy 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kuppili Neelima Reddy 
Designation  PG student 
Affiliation  Maeers physiotherapy college 
Address  Maeers physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin no A-230 talegoan dabhade maval pune

Pune
MAHARASHTRA
410507
India 
Phone  9518728946  
Fax    
Email  rneelima2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sayli Paldhikar 
Designation  professor 
Affiliation  Maeers physiotherapy college 
Address  Maeers physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin no A-230 talegoan dabhade maval pune

Pune
MAHARASHTRA
410507
India 
Phone  8805174616  
Fax    
Email  saylithuse@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sayli Paldhikar 
Designation  professor 
Affiliation  Maeers physiotherapy college 
Address  Maeers physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin no A-230 talegoan dabhade maval pune

Pune
MAHARASHTRA
410507
India 
Phone  8805174616  
Fax    
Email  saylithuse@gmail.com  
 
Source of Monetary or Material Support  
Maeers physiotherapy college near railway station talegoan dabhade pune 410507 
 
Primary Sponsor  
Name  Maeers college of physiotherapy  
Address  Maeers physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin no A-230 talegoan dabhade maval pune 410507 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sayli Paldhikar   Maeers physiotherapy college talegoan dabhade  Maeers physiotherapy college near railway station 2nd floor neurophysiotherapy department cabin no A-230 talegoan dabhade maval pune
Pune
MAHARASHTRA 
8805174616

saylithuse@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maeers college of physiotherapy ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional Physiotherapy   In conventional Physiotherapy balance and gait training exercises will be given for 12 weeks 3 times per week for 60 minutes. 
Comparator Agent  Pediatric endurance and limb strengthening (PEDALS)  In Pediatric endurance and limb strengthening (PEDALS) cycle ergometer will be used where the children will sit on the stationary cycle. The cycling intervention is divided into lower extremity strengthening and cardiorespiratory endurance and prior to cycling manual stretching will be given for 5 to 10 minutes. This intervention will be given for 12 weeks 3 times per week and for 60 minutes. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Children diagnosed with spastic diplegic cerebral palsy.
2. Gross Motor Function Classification Scale (GMFCS) Levels I to III 
 
ExclusionCriteria 
Details  1. Orthopedic surgery, neurological surgery or baclofen pump implantation within the preceding 12 months.
2. Serial casting or new orthotics within the preceding three months.
3. Serious medical conditions such as cardiac disease, diabetes or uncontrolled seizures.
4. Significant hip, knee or ankle joint contractures preventing passive movement of the lower limbs through the pedaling cycle.
5. Children with hip, knee, ankle ROM insufficient to perform cycling will be excluded
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
balance (limits of stability) neurocom balance master  pre and post intervention of 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Gait speed (pediatric dynamic gait index scale)  pre and post intervention of 12 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cerebral palsy is a group of permanent disorder that is caused by non-progressive insult to the fetal brain leading to disorders of development of movement and posture. The overall pooled prevalence of cerebral palsy in India is around 2.95 per 1000 live births. 

    Spasticity, dystonia, contractures, gait and balance disturbances, selective loss of motor control, and muscular weakness are the impairments associated with cerebral palsy. The four major subtypes of CP are spastic, athetoid, ataxic, and mixed CP, spastic forms being the most common form. the most problems in children with spastic CP are spasticity in extremity muscles. If physiotherapy treatment is not started early motor impairment will lead to reduced physical activity and associated complications in adult life. Physical activity exercises which include the strengthening and endurance exercises were not given to patients with spastic cerebral palsy due to the reason that these exercises will increase the spasticity and abnormal movement patterns.  Scientific evidence has not supported this concern and currently the research implies that resistive exercise is an effectual intervention to enhance strength and function in children with CP. Due to the paucity of previous research that has critically examined the effect of stationary cycling for children with CP the PEDALS Project for children with CP was designed as a Phase I RCT.  Pedals is the pediatric endurance and limb strengthening protocol designed for cerebral palsy children where strengthening and the endurance program both are carried out on a stationary cycle. Pedal Cycling is an effective rehabilitation tool that can be added to the physical therapy program which promotes high speed of movement by improving muscle control more than other daily activities performed by most of CP children. Pedals intervention provides progressive resistance exercise for lower extremity musculature. Cycle ergometer can be used in children with CP to improve lower limb muscular strength, endurance, balance, gait and upper limb function. It allows cyclic rotations in passive, active, and endurance modes, promoting an activity that is safe and fully adaptable to the disabilities of this population. motor function has been improved post long-term ergometer exercise, they are easy to perform and quantify the amount of load, these makes them suitable for upper and lower extremity exercises. In neuro-rehabilitation promoting, maintaining and enhancing gait function are the ultimate therapeutic goals. To achieve these there are many other interventions used one of them is cycling. The kinematics of walking and cycling are similar except that in cycling there is greater minimum to maximum flexion at the knee, more posterior pelvic tilt, more external rotation of hip, less ankle plantar flexion and less ankle excursion than walking. Therefore, cycling is a simplified locomotor pattern. Cycling can improve muscle strength, balance and gross motor function in children with cerebral palsy.  Cycling involves bilateral training which improves inter- and intralimb timing parameters. These are major parameters for balanced standing or walking.  Repeated pedaling exercise can reduce the hypersensitivity of the muscle spindle, leading to decrease spasticity. Also, repeated pedaling exercise may activate upper motor neurons leading to recovery of the balance between activation and inhibition of spinal reflexes. Because pedaling facilitates selective muscle activation with less co-contraction of antagonists, it can potentially be an effective mode of muscle re-education. Cycling and walking is a shared neural circuitry as both require reciprocal motor coordination. While cycling loading is decreased through the lower limbs because of seated support. Also, simultaneous strengthening of hip, knee and ankle musculature is seen as all the three joints are highly coupled and move in unison. Movement speed and inertial properties of the limbs influences muscular activity and coordination.  During cycling for the major lower extremity joint extensors and flexor the Normative adult data demonstrates that there is a significant muscle recruitment, based on electromyography (EMG).  During the propulsive phase (limb extension) and during the recovery phase (limb flexion) there is mean recruitment of at least 50% of maximum EMG for the soleus, gastrocnemius, hamstring, vastus medialis/lateralis, rectus femoris, gluteus maximus muscles and tibialis anterior muscle respectively. Prolonged periods of knee and ankle muscle coactivation occurred in children with CP who underwent a single stationary cycling intervention.  Similar to reciprocal stepping, bipedal cycling allows cerebral palsy children to practice accuracy in timing and movement of lower limbs as well as to learn the effective muscle usage of the affected leg during exercise. The positron emission tomography study during cycling movement showed that active cycling significantly activated areas bilaterally in the primary sensory cortex, primary motor cortex, and supplementary motor cortex and in the anterior part of the cerebellum. After lower limb cycling exercise there is seen a reduction in lower limb spasticity especially in calf and hamstring muscles. increase in the range of knee extension motion in children with Cerebral Palsy, also an improvement in the antigravity muscles’ strength and lower limb joints range of motion is seen. Child’s motor skills and independence improved post cycling intervention. Balance and walking performance improved post cycling training in persons with chronic stroke.  In Parkinson’s patients the application of bicycling, improved gait-related parameters of balance, walking speed and overall walking capacity. 

P.E.D.A.L.S which is the Pediatric Endurance and Limb Strengthening, this intervention has a structured protocol where the exercise intensity, duration and guidelines for the exercise progression is given, on the other hand the conventional physiotherapy treatment as such does not follow a set protocol while treating the children. This makes an important factor for including the P.E.D.A.L.S protocol in Cerebral Palsy children’s treatment program.

P.E.D.A.L.S intervention was given to children with Cerebral Palsy and results had a positive effect on gross motor function, quality of life and aerobic responses. Limited studies have stated whether P.E.D.A.L.S intervention on lower extremity muscular strength and endurance is having an effect or not on gait speed and balance in children with spastic diplegic cerebral palsy, making it a need for conducting this study.

Control Group (Conventional physiotherapy)

Balance training:

WEEK 1-3

1.     Supine lying position to standing exercise (Supine lying to side sitting to sitting to standing with hand support).

2.     Prone lying position to standing exercise (Prone lying to quadruped to kneeling to half kneeling to standing with hand support).

3.     Sitting position on chair to standing exercise with hand support.

4.     Kneel standing exercise.

5.     Standing alone exercise (1-2 mins).

6.     Stride standing exercise (1-2 mins).

7.     Step standing exercise One limb rested on ground and other limb rested on wooden step (stable surface).

WEEK 4-6

1.      Supine lying position to standing exercise (Supine lying to side sitting to sitting to standing with hand support).

2.      Prone lying position to standing exercise (Prone lying to quadruped to kneeling to half kneeling to standing with hand support).

3.      Sitting position on chair to standing exercise with hand support.

4.      Kneel standing exercise.

5.      Standing alone exercise (2-4 mins).

6.      Stride standing exercise (2-4 mins).

7.      Step standing exercise One limb rested on ground and other limb rested on wooden step (stable surface).

WEEK 7-9

1.          Supine lying position to standing exercise (Supine lying to side sitting to sitting to standing without hand support).

2.          Prone lying position to standing exercise (Prone lying to quadruped to kneeling to half kneeling to standing without hand support).

3.          Sitting position on chair to standing exercise without hand support.

4.          Kneel standing exercise.

5.          Standing alone exercise (4-6 mins).

6.          Stride standing exercise (4-6 mins).

7.          Step standing exercise on uneven surface as on small ball or small balance board.

8.          Standing exercise on the balance board.

9.          Equilibrium reaction training exercises from standing position (Tilting different directions using a balance board).

10.      Protective reaction training exercises from standing position (Pushing the child forward, backward or sideways).

WEEK 10-12

1.          Supine lying position to standing exercise (Supine lying to side sitting to sitting to standing without hand support).

2.          Prone lying position to standing exercise (Prone lying to quadruped to kneeling to half kneeling to standing without hand support).

3.          Sitting position on chair to standing exercise without hand support.

4.          Kneel standing exercise.

5.          Standing alone exercise (6-8mins).

6.          Stride standing exercise (6-8mins).

7.          Step standing exercise on uneven surface as on small ball or small balance board).

8.          Standing exercise on the balance board.

9.          Equilibrium reaction training exercises from standing position (Tilting different directions using a balance board).

10.      Protective reaction training exercises from standing position (Pushing the child forward, backward or sideways).

Gait training:

WEEK 1-3

1-Walking exercise alone between parallel bars forward and backward slowly with bilateral hand support.

2-Walking exercise between parallel bars on stepper with bilateral hand support.

3-Walking exercise between parallel bars over balance board with bilateral hand support.

4-Walking exercise in stepper outside parallel bars with hand support.

5-Side walking exercise outside parallel bars with hand support.

6-Backward walking exercise outside parallel bars with hand support.

7-Walking alone exercise in altered surface conditions, such as on (firm, sand, carpets, ramps, grass, and gravel).

8-Zigzag walking exercise.

 

WEEK 4-6

1-Walking exercise alone between parallel bars forward and backward slowly with bilateral hand support.

2-Walking exercise between parallel bars on stepper with bilateral hand support.

3-Walking exercise between parallel bars over balance board with bilateral hand support.

4-Walking exercise in stepper outside parallel bars with hand support.

5-Side walking exercise outside parallel bars with hand support.

6-Backward walking exercise outside parallel bars with hand support.

7-Walking alone exercise in altered surface conditions, such as on (firm, sand, carpets, ramps, grass, and gravel).

8-Zigzag walking exercise.

 

WEEK 7-8

1-Walking exercise alone between parallel bars forward and backward slowly without bilateral hand support.

2-Walking exercise between parallel bars on stepper without bilateral hand support.

3-Walking exercise between parallel bars over balance board without bilateral hand support.

4-Walking exercise in stepper outside parallel bars without hand support.

5-Side walking exercise outside parallel bars without hand support.

6-Backward walking exercise outside parallel bars without hand support.

7-Walking alone exercise in altered surface conditions, such as on (firm, sand, carpets, ramps, grass, and gravel).

8-Zigzag walking exercise.

9-Walking up low inclined ramp then walking down.

10-Climbing up and down stairs exercise with bilateral hand support.

 

WEEK 9-12

1-Walking exercise alone between parallel bars forward and backward slowly without bilateral hand support.

2-Walking exercise between parallel bars on stepper without bilateral hand support.

3-Walking exercise between parallel bars over balance board without bilateral hand support.

4-Walking exercise in stepper outside parallel bars without hand support.

5-Side walking exercise outside parallel bars without hand support.

6-Backward walking exercise outside parallel bars without hand support.

7-Walking alone exercise in altered surface conditions, such as on (firm, sand, carpets, ramps, grass, and gravel).

8-Zigzag walking exercise.

9-Walking up low inclined ramp then walking down.

10-Climbing up and down stairs exercise without bilateral hand support.

 

Experimental group (Conventional physiotherapy +P.E.D.A.L.S protocol)

•       Conventional Physiotherapy (similar as mentioned above)

•       P.E.D.A.L.S (Pediatric endurance and limb strengthening) protocol.

1.      5-10 mins warm up (prior to cycling)

 Passive manual stretching will be applied to the muscles of lower limb that are tensed (bilateral hip flexor, knee extensor, knee flexor, ankle plantar flexor).

2.      Cycling intervention will be divided into 2 phases:

a.      Lower extremity strengthening.

b.      Cardiorespiratory endurance.

Lower extremity strengthening (10-15 mins)

•       Lower extremity resistance training will begin with keeping the resistance of cycle ergometer to 1.

•       If participant is able to cycle in a smooth pattern without difficulty for ten complete pedaling revolutions a resistance will be increased to 2.

•       The above protocol will be repeated until the subject cannot cycle at the next higher level of resistance.

•       In subsequent sessions subject will begin with a minimum of 20 revolutions.

•       Further will progress to the maximum resistance level, gradually increasing the number of revolutions.

•       Cardio respiratory endurance training.

•       During first intervention session, participant will be instructed in the use of Children’s effort rating table (CERT)18 for perceived exertion.

•       At the beginning of session resting heart rate will be recorded.

•       Target heart rate of 70 to 80% of HRmax will be calculated using Karvonen formula [(HRmax - HRrest) * (0.70/0.80)] + HRrest].

•       If child is able to cycle for 10 consecutive minutes within the THR range.

•       Intensity of the resistance is increased with a setting of 60 cycles per minute for 2 minute period.

•       Initial session – 15 mins of cycling.

•       Child will be asked to describe their perceived exertion during cycling session using the CERT18.

•       If HR is below target range but the participant is cycling at a high rate, the constant level resistance will be increased.

•       Participants will be encouraged to gradually increase their exercise to a maximum of 30 mins over the 30 sessions.

  1. Cool down period at the end of intervention where participant pedals without resistance until HR decreases to within 20 beats above baseline.
 
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