| CTRI Number |
CTRI/2025/09/094264 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| 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
|
To study the effect of joint mobilisation of wrist joint movement and hand functional movement in patients with stroke |
|
Scientific Title of Study
|
Effectiveness of maitland mobilization on wrist range of motion and hand motor function in subacute stroke patients A randomized controlled trial |
| 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 Akshada Aher |
| Designation |
Post graduate student |
| Affiliation |
Dr. G. D. Pol Foundation YMT College |
| Address |
Dr. G. D. Pol Foundation
YMT College of Physiotherapy, Neuro department, OPD no. 301 Institutional Area Belpada Rd Sector 4 Kharghar Navi Mumbai Maharashtra
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8433566063 |
| Fax |
|
| Email |
aherakshada00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharda Bhalerao |
| Designation |
Associate professor |
| Affiliation |
Dr. G. D. Pol Foundation YMT College |
| Address |
Dr. G. D. Pol Foundation
YMT College of Physiotherapy
Neuro department, OPD no. 301 Institutional Area Belpada Rd Sector 4 Kharghar Navi Mumbai Maharashtra
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9850059332 |
| Fax |
|
| Email |
bhaleraosharda90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharda Bhalerao |
| Designation |
Associate professor |
| Affiliation |
Dr. G. D. Pol Foundation YMT College |
| Address |
Dr. G. D. Pol Foundation
YMT College of Physiotherapy
Neuro department, OPD no. 301 Institutional Area Belpada Rd Sector 4 Kharghar Navi Mumbai Maharashtra
MAHARASHTRA
410210
India |
| Phone |
9850059332 |
| Fax |
|
| Email |
bhaleraosharda90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G. D. Pol Foundation
YMT College of Physiotherapy, Neuro department, OPD no. 301 Institutional Area Belpada Rd Sector 4 Kharghar Navi Mumbai Maharashtra , 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Akshada Aher |
| Address |
Dr. G. D. Pol Foundation
YMT College of Physiotherapy Institutional Area Belpada Rd Sector 4 Kharghar Navi Mumbai Maharashtra 410210 |
| Type of Sponsor |
Other [] |
|
|
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 Akshada Aher |
Dr. G. D. Pol Foundation ; YMT |
Neuro department, opd no.301, Institutional Area Belpada Rd Sector 4 Kharghar Navi Mumbai Maharashtra 410210
Raigarh
MAHARASHTRA |
08433566063
-
aherakshada00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. G. D. Pol Foundation,YMT College of Physiotherapy, Institutional area |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Conventional therapy exercises |
i.In supine lying, active assisted movement for the paretic upper limb; 15 repetitions each; 1 sets.
Patients upper extremity will be taken in elevation with elbow straight and taking back to resting position.
With the sound limb the both the hands will be clasped and raised above head with assistance by maintaining elbow in extension.
Both the arms will be moved side to side an diagonally each side with help of wand.
ii. With ice pack sustained application in proximal to distal direction for inhibition of 5 minutes will be given over the palmar aspect of forearm.
iii. In quadripod position with elbow extended fully, weight shifting forward and backwards and sideways with 10 repetitions each ,1 set excluded in subluxated shoulder
iv.Pelvic bridging, straight leg raise exercise with assistance , 5 secs hold; 10 reps
v.Sit to stand with assistance ;10reps
vi.In standing -weight bearing on paretic arm with elbow extended and lifting sound limb ;10mins |
| Intervention |
Maitland Mobilisation |
Maitland mobilisation for wrist joint along with conventional exercises for total duration of 45 mins for 4 weeks 5 days per week.
Grade 3 (Large amplitude rhythmic oscillating mobilisation to point of limitation in range of movement) volar glide for wrist (radiocarpal joint) extension and dorsal glide for wrist (radiocarpal joint) flexion according to concave and convex rule will be given in resting position for the total duration of 10 mins
once a day. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinically Pre-diagnosed with CT or MRI Intracerebral Hemorrhagic or MCA Ischemic CVA
Conscious, well oriented and co-operative
MMSE score more than equal to 24
Onset of stroke 1 week more than equal to 6 month
1, 1+ and 2 Modified Ashworth Scale Grade for Wrist flexor spasticity
Both Right and Left sided Hemiplegia
|
|
| ExclusionCriteria |
| Details |
Wrist subluxation
Other neurological deficits like parkinsons, multiple scelorosis
Other musculoskeletal disorders like ligament injury
Trauma like fracture or implants of afffcted arm
Other joint disease like active rheumatism |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Range of motion by Standard Goniometer
2. Modified Ashworth Scale |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chedoke Arm and Hand Activity Inventory |
Week 4 |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
15/09/2025 |
| 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)
|
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
|
Spasticity is more frequently presented in the upper extremities than in the lower extremities, with the development of abnormal synergy patterns and it has been considered as a major determinant of activity limitations. To find out the effect of Maitland mobilization on wrist Range of Motion by using standard goniometer in subacute stroke patients. The purpose of the study is to find out the effect of Maitland mobilization on hand motor function by using CAHAI scale in subacute stroke patients and to find out the effect of Maitland mobilization on wrist flexor muscle spasticity by using Modified Ashworth Scale in subacute stroke patients. Will there be any effect of 4 weeks Maitland mobilization intervention on wrist range of motion and hand motor function in subacute stroke patients.
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