| CTRI Number |
CTRI/2023/03/050356 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| 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
|
Retraining of balance, nerve glide exercises, resistance training, and instruction in daily living skills are effective treatments for chemotherapy-induced peripheral neuropathy in cancer survivor |
|
Scientific Title of Study
|
Efficacy of balance re-education, neural mobilisation, resistive and activities of daily living training on chemotherapy induced peripheral neuropathy in cancer survivors: Two arm randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HIMANSHU GAKHAR |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY |
| Address |
Karkar Duma, Karkardooma, Anand Vihar, Delhi, 110092
New Delhi
DELHI
110045
India |
| Phone |
7982602897 |
| Fax |
|
| Email |
gakharhimanshu793@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIDHI SINGH PT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY |
| Address |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY,
KARKARDOOMA, VIKAS MARG, NEW DELHI- 110092
EAST
DELHI
110092
INDIA
East
DELHI
110092
India |
| Phone |
|
| Fax |
|
| Email |
nidhi.singh2411@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NIDHI SINGH PT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY |
| Address |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY,
KARKARDOOMA, VIKAS MARG, NEW DELHI- 110092
EAST
East
DELHI
110092
India |
| Phone |
|
| Fax |
|
| Email |
nidhi.singh2411@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY
Karkar Duma, Karkardooma, Anand Vihar, Delhi, 110092 |
|
|
Primary Sponsor
|
| Name |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY |
| Address |
AMAR JYOTI INSTITUTE OF PHYSIOTHERAPY,
KARKARDOOMA, VIKAS MARG, NEW DELHI- 110092
|
| Type of Sponsor |
Private medical college |
|
|
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 Ajay Dabas |
JIVISHA ADVANCE MEDICAL CENTER |
2nd floor Chemotherapy ward Room number 1, 29, Paschim Vihar Extension, Paschim Vihar, Delhi, 110063
West
DELHI |
9811819057
dabas.ajay131@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| AMAR JYOTI INSTITUIONAL REVIEW BOARD- ETHICAL COMMITTEE |
Approved |
| JIVISHA ADVANCE MEDICAL CENTER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
balance re-education, neural mobilisation, resistive and activities of daily living training |
1. Balance Re-education a. Standing on one foot
b. Sit to stand
c. Medio-lateral and Antero-posterior Perturbations
d. Walking in figure of 8
2. Neural mobilisation
3. Resistive Training
(with weight cuff)
Front raise
Lateral raise
Knee Flexion- Extension
Hip Flexion-Extension
Ankle Dorsiflexion
Ankle Plantar flexion
4. Activities of Daily Living training
Walking
Star climbing (5 steps)
Shoe lacing
The complete program lasted for 40-45 minutes for 3 weeks.
|
| Comparator Agent |
Education regarding chemotherapy induced peripheral neuropathy its consequences and role of exercises. |
Control participants will be given education, counseling without additional information about physical activity. During follow up, when all assessments are done, control group patients will have the opportunity to participate in the intervention described for a maximum of 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
- Age 18-60 years had primary diagnosis of cancer
- Given chemotherapeutic regimen for atleast 1 cycle
- Both Male and female
- All types of cancer
- Had a karnofsky performance status ≥ 70
- Should be able to walk 3 meters
- Have at least 1 neuropathy symptom according to CIPN assessment tool (CIPNAT).
|
|
| ExclusionCriteria |
| Details |
- Hereditary peripheral neuropathy .{ e.g., Charcot-marie-tooth disease}
- If they had other chronic neuropathic disease likes Diabetic Neuropathy, Multiple Sclerosis, Neuritis etc.
- Orthopaedic problem that affect balance (e.g. ACL reconstruction)
- Vestibular disorder and visual acuity problem
- Chronic inflammatory demyelinating polyneuropathy
- Concomitant disease like diabetes, renal insufficiencies
- Prior history of alcohol abuse
- Lower limb amputee
- Use of walking Aid
- Treatment with antiepileptic drugs, antidepressants and major analgesics.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified total neuropathy score A 6 -item tool that combines patient report of subjective sensory and motor symptoms, deep tendon reflexes, manual muscle testing of distal muscles, pin sensibility, and quantitative vibration thresholds.
• 0 -24 points, higher score indicates worse neuropathy.
|
will be assessed at baseline and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
UNIPEDAL STANCE TEST
• Patients were asked to stand barefoot on the limb of their choice, with the other limb raised so that the raised foot was near but not touching the ankle of their stance limb.
• Prior to raising the limb, the subject was instructed to cross his arms over the chest.
• The investigator used a stopwatch to measure the amount of time the subject was able to stand on one limb.
• Time commenced when the subject raised the foot off the floor ended when the subject either
(1) used his arms (ie, uncrossed arms)
(2) used the raised foot (moved it toward or away from the standing limb or touched the floor)
(3) moved the weight-bearing foot to maintain his balance (ie, rotated foot on the ground)
(4) a maximum of 45 seconds had elapsed
(5) opened eyes on eyes closed trials.
|
The test/Questionaire will be assessed at the baseline and at the end of 3 weeks. (Pre and Post) |
| timed up and go test |
The test/Questionaire will be assessed at the baseline and at the end of 3 weeks. (Pre and Post) |
| functional independence measure |
The test/Questionaire will be assessed at the baseline and at the end of 3 weeks. (Pre and Post) |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
11/03/2023 |
| 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
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is rising prevalence of cancer, many individuals are living with side effects of its treatment, as chemotherapy is the mainline treatment. Few studies have been done to investigate potentially beneficial effects of specific exercise to counteract chemotherapy induced peripheral neuropathy symptoms in cancer survivors. The rehabilitative potential of exercise has been so far less investigated and the results are divergent. The majority of studies are done on non natives of India focusing on one or two protocols only at one time. So there is need to investigate the effect of balance Re-education, neural mobilisation, Resistive and activities of daily living training in chemotherapy induced peripheral neuropathy on cancer survivors. In this study following procedure will be followed:
1. The purpose and benefit of the research will be explained to the cancer
survivors having Chemotherapy induced peripheral neuropathy 2. Consent for participation in research will be taken from the patients 3. Meeting the inclusion and
exclusion criteria 4.Baseline assessment will
be performed
Patient divided into
two groups
|
EXPERIMENTAL GROUP
|
CONTROL GROUP
|
|
N = 14
|
N = 14
|
|
Will be given intervention
exercises, With proper guidance, counseling and precautions.
|
Education regarding chemotherapy
induced peripheral neuropathy its consequences and role of exercises.
|
|