Effects of Proprioceptive Training and Partial Body Weight Supported Treadmill Training on Balance and Functional Mobility in Children with Spastic Diplegia: A Randomized Controlled Trial.
To improve balance and functional mobility in children with spastic diplegia by applying proprioceptive training and partial bodyweight supported treadmill training.
Design
Randomized controlled trial
Settings and conduct
Randomized controlled study was conducted in children hospital Faisalabad. Assessor was blinded.
Participants/Inclusion and exclusion criteria
Spastic diplegic cerebral palsy, Both gender, 11-13 years old, Spasticity of grade <2 according to the Modified Ashworth Scale, Level 2-3 (GMFCS), Intact cognitive status, Normal Vision and hearing status were included
whereas patients with, Seizures, any surgical procedure 6 months ago, fixed Joint contractures, Bony deformity i.e. Scoliosis, windswept deformity, crouch knee deformity, Rocker Bottom deformity etc. Multiple medical concerns i.e. Any Cardiac issue and Asthma etc. Medicines to reduce spasticity were excluded.
Intervention groups
In Control Group patients practiced proprioceptive training in form special seven exercises.
All the proprioceptive exercises was performed for 30 minutes per session with 5 minutes rest period in between for 3 days a week and continued for 12 weeks.
whereas in Experimental group Patients were treated with proprioceptive exercises in addition of treadmill training program which was conducted 3 times/week for 12 successive weeks. Patients practiced one hour session of treatment including 30 minutes of Proprioceptive training and 30 minutes of treadmill training. A specialized Harness was used with treadmill training to ensure safety of a patient. Treadmill speed started at 0.5 km/h~1.0 km/h and increased gradually according to children’s adaptability by 0.1 km/ h progressively to suit the child’s speed.
Main outcome variables
Balance and Functional mobility was the main outcomes measure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210818052225N1
Registration date:2021-08-22, 1400/05/31
Registration timing:retrospective
Last update:2021-08-22, 1400/05/31
Update count:0
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Benish Shakoor
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 41 8756972
Email address
benishshakoor294@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2019-12-11, 1398/09/20
Actual recruitment start date
2019-12-12, 1398/09/21
Actual recruitment end date
2019-12-28, 1398/10/07
Trial completion date
2020-03-28, 1399/01/09
Scientific title
Effects of Proprioceptive Training and Partial Body Weight Supported Treadmill Training on Balance and Functional Mobility in Children with Spastic Diplegia: A Randomized Controlled Trial.
Public title
Effects of Proprioceptive Training and Partial Body Weight Supported Treadmill Training on Balance and Functional Mobility in Children with Spastic Diplegia: A Randomized Controlled Trial.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Spastic diplegic cerebral palsy •
Both gender
11-13 years old
Spasticity of grade <2 according to the Modified Ashworth Scale
Level II-III (Gross Motor Functional Classification System)
Intact cognitive status (Mini Mental State Examination, level 9-20 will be included )
Normal Vision and hearing status.
Exclusion criteria:
Seizures
Patients who had gone through any surgical procedure related to spine and extremities 6 months ago
Patients with fixed Joint contractures
Bony deformity i.e. Scoliosis, windswept deformity, crouch knee deformity, Rocker Bottom deformity etc.
Multiple medical concerns i.e. Any Cardiac issue and Asthma etc.•
Medicines to reduce spasticity
Patients already involve in Treadmill training at home
Age
From 11 years old to 13 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
After fulfilling the inclusion criteria patients were divided randomly into experimental and control group. Patients were randomized individually. They were distributed by random numbers. Allocation was concealed in envelops. Researcher was unaware of treatment given to patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor was unaware about the patients from both groups. He was allowed to assess data before giving intervention and after the complete duration of twelve weeks. He was unaware of treatment given to participants.
Placebo
Not used
Assignment
Parallel
Other design features
Randomized controlled study design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review of Board of University of Lahore
Street address
Defence road Lahore
City
Lahore
Postal code
54590
Approval date
2020-12-03, 1399/09/13
Ethics committee reference number
IRB-UOL-FAHS/767/2020
Health conditions studied
1
Description of health condition studied
Spastic diplegic cerebral palsy
ICD-10 code
G80.1
ICD-10 code description
Spastic diplegic cerebral palsy
Primary outcomes
1
Description
Balance
Timepoint
before intervention and after twelve weeks of intervention
Method of measurement
Pediatric Balance scale
Secondary outcomes
1
Description
functional mobility
Timepoint
Before intervention and after 12 weeks of intervention
Method of measurement
Timed Up and Go Test (TUG) was used to measure functional mobility.
Intervention groups
1
Description
Participants in control group were practiced proprioceptive training with specialized proprioceptive exercises. 1: Stair climbing up and down (regular 3 steps staircase).2: Standing with feet approximately shoulder-width apart with arm extending lower than shoulder then lifting the both heels from the floor an d maintain for 10 sec, followed by climbing regular steps3: One foot placed on inside of the opposing ankle and hold the position for 10 sec followed by climbing regular steps staircase.4: One leg standing with one foot raised to back and maintain this position for minimum 3 seconds. This procedure is performed with eyes closed also.5: Same procedure as described above with one foot raised to the front.6: Walking heel to toes.7: Rising from a standard chair 4 times without support. All proprioceptive exercises was performed for 30 minutes per session with 5 minutes rest period in between for 3 days a week and continued for 12 weeks.
Category
Rehabilitation
2
Description
Patients were treated with proprioceptive exercises in addition of treadmill training program which was conducted 3 times/week for 12 successive weeks. Patients practiced one hour session of treatment including 30 minutes of Proprioceptive training and 30 minutes of treadmill training. A specialized Harness was used with treadmill training to ensure safety of a patient. After Proprioceptive exercises treadmill training subdivided into 3 sets with 10 minutes each. During first and last 5 minutes, child walked at 60% maximal speed while during remaining 20 minutes, they performed walking at 80% maximal speed. 5 min rest after each set of training to prevent fatigue. Treadmill speed started at 0.5 km/h~1.0 km/h and increased gradually according to children’s adaptability by 0.1 km/ h progressively to suit the child’s speed.