| CTRI Number |
CTRI/2020/03/024241 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A rehabilitation protocol for craniotomy patient after surgery in ICUs. |
|
Scientific Title of Study
|
Effectiveness of Rehabilitation protocol for early management of Craniotomy patients to improve Functional Outcomes in Intensive Care Unit. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1248-9270 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Apoorva Srivastava |
| Designation |
Student |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR) |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,Department of physiotherapy and rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
6387810307 |
| Fax |
|
| Email |
apoorva.pt12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Sharma |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR) |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Department of physiotherapy and rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
7906134419 |
| Fax |
|
| Email |
sharma.nidhi.physio@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adarsh Kumar Srivastav |
| Designation |
URF (University Research Fellowship) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation (MMIPR) |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Department of physiotherapy and rehabilitation, Maharishi Markandeshwar Deemed to be University, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8618889003 |
| Fax |
|
| Email |
adarsh.srivastav@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Apoorva Srivastava
2/365-G, nawabganj, Kanpur-208002 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
| Address |
MMIPR, Maharishi Markandeshwar Deemed to be University, Mullana-Ambala, Haryana-133207 |
| Type of Sponsor |
Private medical college |
|
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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 Nidhi Sharma |
Neurological ICU |
Department of NEURO ICU, 2nd floor, Maharishi Markandeshwar Superspeciality Hopsital, Mullana-Ambala.
Ambala
HARYANA |
7906134419
sharma.nidhi.physio@mmumullana.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi markandeshwar deemed to be university, institutional ethics committee, mullana, ambala |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 Trans-cranial direct electrical stimulation
2 Music therapy
3 Coma stimulation therapy
4 Sensory integration therapy
5 Motor function training
6 Chest physiotherapy
7 Mobility training
|
1. Chest physiotherapy- Patients often develop secondary complications of the chest congestion, breathing abnormalities and respiratory functional abnormalities for which the patients will be rendered with vigorous chest physiotherapy including vibration, percussion, bilateral segmental expansion of the chest to overcome the possibility of development of ventilator acquired pneumonia, cough congestion in bronchus and lung segments, etc.
2. Limb physiotherapy- In initial stages this includes providing passive range of motion exercises, followed by assisted and active range of motion exercises as the patient gains consciousness and returns to stage of cooperation. To improve muscle tone in patients it is important to give stretching techniques to specified muscle groups which can undergo weakness and even atrophy in both conscious and unconscious state.
3. Trans-cranial direct electrical stimulation- In various previous studies it has been observed that tdcs shows better results for improving consciousness and cognition hence post craniotomy tdcs will be used for better treatment.
4. Coma stimulation therapy- Coma stimulation therapy is a treatment protocol for recovery of patient from unconsciousness and arousal of patient from persistent vegetative state.
5. Motor functional training- Such type of training is useful once the patient is aroused from unconsciousness and then to strengthen the musculature. Activities promoting in-bed mobility and bed side mobility exercises are taught to patient.
6. Music therapy- Music therapy is seen to elicit anti-depressive periods. This works as the patient receives auditory stimulations which provide relaxation to the patient which in turn enhances cognition and reduces episodes of agitation.
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are ventilated mechanically after the procedure of craniotomy.
2. Patients who are on oxygen support, the amount of oxygen being delivered will depend upon the condition of the patient and it’s saturation.
3. Patients who have undergone tracheostomy.
4. Patients who have undergone craniotomy for reasons such as:
a) Cerebral aneurysm
b) Stereotactic aspiration
c) Extended bifrontal craniotomy followed by bone flap replacement.
d) Minimal invasive supra-orbital craniotomy
e) Removal of blood clot from brain vesels.
f) Drainage of brain abcess
g) Repairing of fractures of the skull
|
|
| ExclusionCriteria |
| Details |
1. Patients who have severe fatal infections following the surgery.
2. Patients who have an unstable vital such as high blood pressure, irregular tachycardia and bradycardia, low saturation level besides proper mechanical ventilation, exaggerated pulse and heart rate monitoring, etc.
3. Patients whose family is not cooperative for the treatment.
4. Patients with secondary infections like ventilator-acquired pneumonia.
5. Patients who have undergone craniotomy for the following reasons:
a) Patients whose brain lobes are removed i.e. lobectomy of the brain segments.
b) Patients who were diagnosed with meningioma.
c) Patients with malignant skull base tumor.
d) Patients who have undergone retro-sigmoid keyhole craniotomy.
e) Patients diagnosed with acoustic neuroma.
f) Patients who have undergone orbitozygomatic craniotomy.
g) Patients with translabryinthine craniotomy.
h) Patients who undergo craniotomy for the process of repair of tear in the duramater.
i) Patients with implanted stimulators.
6. Patients with hearing and visual loss.
7. Patients who are agitated and highly uncooperative post recovery from unconsciousness.
8. Patients who have previous history of any fatal injury.
9. Patients of amputation or amputed extremities before the surgical procedure.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Early Functional Ability Scale (EFA) |
The scale has 4 domains which are further divided into 20 points consisting of 100 scoring marks.It will be take prior to and fter the commencement of the exercsie. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Glasgow Coma Scale (GCS) |
It will be taken prior to commencement of the study and after completion of 15 days. |
| Coma Recovery Scale (CRS)- Revised |
it will betaken before and after the intervention i.e. before commencement and after 15 days. |
| Montreal cognitive assessment scale |
taken before intervention and after the commencement of 15 days intervention. |
| Modified ashworth scale |
it will be taken on the first day and last day of the intervention. |
| Medical research council scale |
It will betaken before giving the treatemnt and after the intervention after 15 days. |
| Sensory modality assessment technique (SMAT) |
It will be taken before and after the 15 days treatment protocol. |
| Chest X-ray |
It will be seen before and after treatment intervention of 15 days. |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/04/2020 |
| Date of Study Completion (India) |
15/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
BACKGROUND: Craniotomy is a widely used procedure which has several complications in terms of neurological, cardiovascular, psychological, etc. patients who have undergone craniotomy are subjected to physiotherapeutic interventions once these complications arise in patients. As a matter of fact many studies have been done over the management of patients in intensive care units but the evidences for a defined protocol to be followed particularly for craniotomy patients is negligible. OBJECTIVE: The objective of the study is to test the effects of a rehabilitation protocol for patients undergoing craniotomy from the day of surgery which will prevent complications to occur in such patients enhancing their functional outcomes which in turn improves their quality of life. METHODOLOGY: It is a single group pre-test post-test experimental design in which patients will be given a pre-set 75 minutes based protocol for preventing the complications after craniotomy. From the day of surgery upto 15th day patients will be administered with protocol being progressive according to the condition of patient. Progression of protocol will depend upon the response of patient to treatment being given and alterations in his/her heath condition. It will be a single blinded study. RESULTS: Result of study will be checked by certain outcome measures like Early functional ability scale (EFA), Glasgow coma scale, montreal cognitive assessment, coma recovery scale-revised, medical research council scale, modified ashworth scale, sensory modality assessment technique and chest X-rays. The assessment at the baseline prior to commencement of study will be taken and then at completion of 15 day interval. DISCUSSION: Effect of not only single interventions can be seen but following a rehabilitation protocol will help the patient to functionally overcome probable side-effects of the surgery. KEY WORDS: Craniotomy, Glasgow coma scale, Intensive Care Unit, Quality of life. |