| CTRI Number |
CTRI/2025/01/079215 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| 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
|
Comparing offline and online balance training for cancer patients with nerve damage |
|
Scientific Title of Study
|
Institution versus Tele-Rehabilitation based balance training program for Chemotherapy Induced Peripheral Neuropathy in Cancer Population |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elizabeth Lobo |
| Designation |
MPT Student |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Department of Physiotherapy, Ground Floor, Nanavati Max Super Specialty Hospital,SV Road,Vile Parle(W)
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9082418028 |
| Fax |
|
| Email |
loboelizabeth521@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabah Thaver |
| Designation |
Assisstant professor- physiotherapist |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Department of Physiotherapy, 7th floor Mithibai College Building, Bhaktivedanta Road, Vile Parle West
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9820691076 |
| Fax |
|
| Email |
Sabah.Thaver@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabah Thaver |
| Designation |
Assisstant professor- physiotherapist |
| Affiliation |
Sunandan Divatia School of Science |
| Address |
Sunandan Divatia School of Science, Department of Physiotherapy, 7th floor Mithibai College Building, Bhaktivedanta Road, Vile Parle West
Mumbai
MAHARASHTRA
400056
India |
| Phone |
9820691076 |
| Fax |
|
| Email |
Sabah.Thaver@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy ,ground floor, Nanavati Max Super Specality Hospital, SV Road, Vileparle west,Mumbai-400056 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [ NIL] |
|
|
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 Ali Irani |
Nanavati Max Super Specialty Hospital |
Department of physiotherapy, Ground
Floor, SV Road, Vileparle west
Mumbai
MAHARASHTRA |
02261347560
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nanavati Max Super Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Institution based balance training |
It is a 4 week intervention with total 12 Sessions - 3 sessions per week (alternate days)
|
| Comparator Agent |
Tele - Rehabilitation based balance training |
It is a 4 week intervention with total 12 Sessions - 3 sessions per week (alternate days)
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with cancer assigned to receive a chemotherapeutic regimen and has finished the regimen for at least a month.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity score must be less than 76.
Patients with controlled diabetes mellitus having HBA1c up to 7%.
|
|
| ExclusionCriteria |
| Details |
Individuals with vision or auditory disorders.
Patient with cognitive challenges, MoCA score equal to or more than26.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mini BEST test |
Baseline and post 4 weeks of Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 10m Walk test |
Baseline & post 4 weeks of Intervention
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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 2 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="0"
Months="6"
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
|
TITLE: Institution versus Tele - Rehabilitation based balance training program for Chemotherapy Induced Peripheral Neuropathy in Cancer Population INTRODUCTION: The National Cancer Institute defines cancer as a disease characterized by the uncontrolled division of abnormal cells, which can invade surrounding tissues and spread to other parts of the body known as metastatic cancer. The burden of cancer can be alleviated through early detection, preventive strategies such as lifestyle modifications, and the use of frontline chemotherapeutic agents.Though patients with chemotherapeutic interventions in combating cancer, may experience a range of adverse side effects that includes peripheral neuropathy as one of the major effect that negatively impacts one’s own bodily function. A complex interplay of physical, neurological, and sensory impairments leads to imbalance that gives rise to a high risk of fall. RATIONALE: Balance training reduces fall risk by enhancing proprioception, training reactive balance, improving muscle strength and coordination. By incorporating balance training into CIPN management, patients can regain confidence in their mobility, reduce their fall risk, and improve overall functional outcomes. AIM: To assess the effect of institution versus tele - rehabilitation
based balance training program in patients with Chemotherapy induced peripheral
neuropathy. OBJECTIVES: To assess the effect of institution based balance
training program in patients with Chemotherapy induced peripheral neuropathy. To
assess the effect of tele - rehabilitation based balance training program in
patients with Chemotherapy induced peripheral neuropathy. To
compare the results obtained in all 2 groups. OUTCOME MEASURES: 1. 10m walk test - To assess walking speed in m/s. 2. mini BEST test - to assess balance. PROTOCOL: The intervention was developed using Horak’s theoretical balance framework which describes 6 interacting systems contributing to balance control : Biomechanical Constraints, Staability Limits, Verticality, Anticipatory Postural Adjustments, Postural Adjustments, Sensory Orientation and Stability in Gait. Individuals will be asked to rate each of the exercise at the end of the session using a ten-part Likert scale (10 being the greatest level of challenge and 1 being no challenge). Exercise levels will be tailored to each individual and will be progressed to increase challenge level when perceived challenge to balance is less than 7. Initially variable surface conditions and later exercises with eyes closed will be performed. Frequency - Thrice a week for 4 weeks, Intensity – 10 repetitions/exercise, Duration - 45 minutes, Type – Balance Training.
|