| CTRI Number |
CTRI/2024/04/065840 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
07/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Perturbation Balance Training on Pain Intensity, Walking and Functions in Rehabilitation of Avascular necrosis patients Leading to Total Hip Replacement. |
|
Scientific Title of Study
|
Efficacy of Perturbation Balance Training on Pain, ROM, Gait and Functional Independence in Rehabilitation of AVN patients Leading to Total Hip Replacement: A Randomized Control Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aishwarya Borhade |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Musculoskeletal Physiotherapy, Room no 16, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU),Sawangi(Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8104062326 |
| Fax |
|
| Email |
aishwaryaborhade1109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratik Phansopkar |
| Designation |
Professor & HOD |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Musculoskeletal Physiotherapy, Room no 16, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU),Sawangi(Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
9890827710 |
| Fax |
|
| Email |
drpratik77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratik Phansopkar |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Musculoskeletal Physiotherapy, Room no 16, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU),Sawangi(Meghe)
MAHARASHTRA
442001
India |
| Phone |
9890827710 |
| Fax |
|
| Email |
drpratik77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research(DU), Sawangi (Meghe), Wardha, 442001 |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department of Musculoskeletal Physiotherapy,Ravi Nair Physiotherapy College, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Higher Education and Research(DU), Sawangi (Meghe), Wardha, 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Aishwarya Anand Borhade |
Acharya Vinoba Bhave Rural Hospital, Ravi Nair Physiotherapy College, |
IN patient department orthopedic ward IPD no 33 TKR & THR Department, Room number D/201, Department of Musculoskeletal Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Eduction and Research [DU], Sawangi
Wardha
MAHARASHTRA |
8104062326
aishwaryaborhade1109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research(DU), Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M161||Unilateral primary osteoarthritisof hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
In control group, patient will be receiving conventional exercises post total hip replacement.
Sessions will be conducted twice a week for 4 weeks. This program includes Active assisted range of motion Hip flexion, hip abduction, knee flexion, knee extension, muscle strengthening, stretching of Hip flexors, hip extensors, adductors, knee flexors, extensors, ankle dorsiflexors, ankle plantarflexors, Transfer training supine to side lying in bed, sit to stand from bed and chair and gait training Using parallel bar and assistive device with weekly one-hour training sessions will be held for 4 weeks Exercises to increase muscle strength,
function, balance, coordination, gait, and joint range of motion consist of conventional
exercises. exercises. After 4 weeks of conventional
exercise patient will be receiving home-based protocol till 8th week. Home base protocol includes Active range of motion Hip flexion, hip extension, hip abduction, knee flexion, knee extension, muscle strengthening hip flexors (moderate-resistance rubber band fixed to the ankle in standing position) o hip abductors (standing position and seated position with moderate-resistance rubber band) knee extensors and flexors (weight-training equipment, in a seated position, 20% 1RM)and climbing and descending stairs
|
| Intervention |
Perturbation Balance Training (PBT) |
This group consists of perturbation balance exercise with conventional exercises
for balance. For participants safety entire session will be monitored closely by certified
physiotherapist. Program includes Active assisted range of motion
Hip flexion, hip abduction, knee flexion, knee extension, muscle strengthening, stretching of
Hip flexors, hip extensors, adductors, knee flexors, extensors, ankle dorsiflexors, ankle plantarflexors, Transfer training supine to side lying in bed, sit to stand from bed and chair and gait training
Using parallel bar and assistive device with weekly one-hour training sessions will be held for 4 weeks; each participant
will complete eight sessions in total. Twenty forward, twenty backward, and forty lateral
perturbations (20 left-to-right and 20 right-to-left) are included in each session with
conventional exercises for 4 weeks. Patient will be on home base protocol till 8th week. Home base protocol includes Active range of motion
Hip flexion, hip extension, hip abduction, knee flexion, knee extension, muscle strengthening hip flexors (moderate-resistance rubber band fixed to the ankle in standing position)
o hip abductors (standing position and seated position with moderate-resistance rubber band)
knee extensors and flexors (weight-training equipment, in a seated position, 20% 1RM)and climbing and descending stairs
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) The diagnosis of hip avascular necrosis through radiological findings.
2) Leading to initial unilateral complete hip replacement
3) No physical exercise carried out during the two months before surgery
4) Patient age criteria 30-45 years |
|
| ExclusionCriteria |
| Details |
1) Hip fracture and OA of hip
2) Complications following surgery, such as dislocation, infection, and cardiovascular
3) Revision arthroplasty
4) Motor function is compromised by neuromuscular diseases
5) Refusal to take part in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numerical pain rating scale
Range of motion
Gait parameters Xsens
Gait parameters |
Base line and after 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Harris Hip Score (HHS)
Manual muscle testing |
Base line and after 4 weeks and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study will be done to evaluate the effects of Perturbation Balance Training on improving pain, ROM, gait and functional independence in rehabilitation of AVN patients leading to total hip replacement. To compare the effects of Perturbation Balance Training and conventional exercise on improving pain, ROM, gait and functional independence in rehabilitation of AVN patients leading tot total hip replacement. The study will be conducted at the Musculoskeletal
physiotherapy Inpatient department
orthopaedic ward IPD no.33 TKR & THR department of AVBRH, RNPC, Sawangi
(Meghe) Wardha. After
getting Ethical Clearance from Institutional Ethical Committee, Patients
diagnosed with avascular necrosis of hip and are planned to undergo Total hip
replacement will be identified from Acharya Vinoba Bhave Hospital. Permission
will be obtained from treating Residents, consent will be taken from the
patient and then patient fulfilling the inclusion criteria will be randomly
divided into two equal groups – Experimental Group and Control Group. Baseline
assessment will be recorded pre surgery.
After the total hip replacement treatment will be given within next day.
Experimental Group will be receiving Perturbation Balance Training along with conventional exercise in order to be focusing
on lower limb sensorimotor function, strength that would increase balance and
thus improving quality of life. Control Group will be receiving conventional
exercise in order to improve balance and thus quality of life. Both the groups
will be receiving intervention for 2 days in a week till 4 weeks and then after
4 weeks of treatment outcome measure will be assessed. Both the groups will be receiving home-based
protocol till 8th week.
Assessment will be taken to evaluate pain, range of motion, strength and
gait.
|