| CTRI Number |
CTRI/2025/04/084275 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| 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
|
Forward-Uphill versus Backward-Downhill gait training in improving balance and gait in children with cerebral palsy. |
|
Scientific Title of Study
|
Comparison of Forward-Uphill with Backward-Downhill gait training on balance and gait in children with 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 |
CHIKATI MANASA |
| Designation |
MASTER OF PHYSIOTHERAPY |
| Affiliation |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY |
| Address |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY, NEURO-OUT PATIENT DEPARTMENT GROUND FLOOR,EXERCISE THERAPY ROOM.
Hyderabad
TELANGANA
500044
India |
| Phone |
8247476910 |
| Fax |
|
| Email |
chikatimanasa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MS.A.DURGA REDDY |
| Designation |
PROFESSOR (DEPARTMENT OF NEUROLOGY) |
| Affiliation |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY |
| Address |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY,NEURO-OUT PATIENT DEPARTMENT,GROUND FLOOR,EXERCISE THERAPY ROOM.
Hyderabad
TELANGANA
500044
India |
| Phone |
9492925784 |
| Fax |
|
| Email |
abbadidurga@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CHIKATI MANASA |
| Designation |
PG student - MASTER OF PHYSIOTHERAPY - NEUROSCIENCES |
| Affiliation |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY |
| Address |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY,NEURO OUTPATIENT DEPARTMENT, GROUND FLOOR, EXERCISE THERAPY ROOM.
Hyderabad
TELANGANA
500044
India |
| Phone |
8247476910 |
| Fax |
|
| Email |
chikatimanasa@gmail.com |
|
|
Source of Monetary or Material Support
|
| DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY(DDCOP),DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTER(DDHRC),DURGABAI DESHMUKH VOCATIONAL TRAINING AND REHABILITATION CENTER(DDVTRC), OSMANIA UNIVERSITY, ADIKMET, HYDERABAD, TELANGANA, INDIA, 500044. |
|
|
Primary Sponsor
|
| Name |
CHIKATI MANASA |
| Address |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY,OSMANIA UNIVERSITY,ADIKMET-500044 |
| Type of Sponsor |
Other [SELF SPONSOR] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr CHIKATI MANASA |
DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTER,DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY |
DURGABAI DESHMUKH COLLEGE OF PHYSIOTHERAPY,NEURO-OUTPATIENT DEPARTMENT ,GROUND FLOOR,EXERCISE THERAPY ROOM.
Hyderabad
TELANGANA |
08247476910
chikatimanasa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE DURGABAI DESHMUKH HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G801||Spastic diplegic cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BACKWARD DOWNHILL GAIT TRAINING |
WARM UP EXERCISES,BACKWARD DOWNHILL GAIT TRAINING,CONVENTIONAL THERAPY,COOL DOWN EXERCISES |
| Comparator Agent |
comparison of Forward Uphill gait training with backward downhill gait training. |
Intervention for Forward Uphill gait training includes warm up exercises, forward uphill gait training, conventional therapy(which includes sitting balance training, standing balance training, weight shifts ,gait training, strengthening exercises, functional training of hand) and cool down exercises.
Intervention for Backward Downhill gait training includes Warm up exercises, backward downhill gait training, conventional therapy(sitting balance training, standing balance training, weight shifts ,gait training, strengthening exercises, functional training of hand) cool down exercises.
|
| Intervention |
FORWARD UPHILL GAIT TRAINING |
WARM UP EXERCISES,FORWARD UPHILL GAIT TRAINING,CONVENTIONAL THERAPY,COOL DOWN EXERCISES. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Children who are diagnosed with Spastic Diplegic Cerebral Palsy.
2.Children under 6-14 years of age with definite diagnosis of Cerebral Palsy and there is no limitation on gender and race.
3.GMFCS I, II and III(Children who are able to walk with assistive devices like walker and cane).
4.Spasticity(Plantar Flexors)with grade 1,1+,2(MODIFIED ASHWORTH SCALE)
5.Mini Mental State Examination (MMSE)score of 24 or above. |
|
| ExclusionCriteria |
| Details |
1.Spasticity(Plantar Flexors)of MAS-grade 4 and 5 children are excluded.
2.Unstable seizure disorders.
3.Children with associated cognitive impairments. example:dementia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Balance using PAEDIATRIC BERG BALANCE SCALE.
Gait using GMFM 88 D and E |
Baseline and at 8 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle Strength using DYNAMOMETER |
Baseline & at 8 weeks after intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
11/04/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 non progressive , neuromotor disorder that affects the movement ,
muscle tone and posture causing limitation of activity in developing fetus or
infant. People
with Cerebral Palsy
may experience abnormalities such as excessive plantar flexion of the ankle,
increased knee flexion with valgus, and heightened hip adduction and internal
rotation. These abnormalities can explain
the challenges individuals with Cerebral Palsy
face in maintaining static balance, dynamic balance and gait. “Forward-Uphill”
gait training increases concentric excursion of
fascicle while “Backward-Downhill” gait training
increases eccentric excursion of fascicle which can
effectively target and improve plantarflexor and dorsiflexor muscle strength
which contribute to improve gait and has large impact balance. Gait training is an important
aspect of therapy for children with Cerebral Palsy, as it can help improve their
walking ability and overall mobility. Forward Uphill and Backward
Downhill gait training specifically focus on plantar flexor and dorsiflexor
muscles enhancing the muscle strength, Gait and balance. As per our literature search, there is a very limited literature comparing the effects of forward
uphill gait training and backward downhill gait training
and scare literature on its effects on balance and gait. The purpose of this study is to
specifically examine and compare the impact of forward uphill and backward
downhill gait training on the enhancement of balance and gait in children
diagnosed with cerebral palsy.
|