| CTRI Number |
CTRI/2025/11/097644 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| 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
|
Effectiveness of theraband and CIMT on walking ability in stroke patients |
|
Scientific Title of Study
|
Effectiveness of theraband and CIMT on lower extremity function of gait in stroke patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhijith S Namboothiri |
| Designation |
Post graduate |
| Affiliation |
Yenepoya physiotherapy college |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru
Yenepoya physiotherapy college, university road, dertakatte, mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8921037554 |
| Fax |
|
| Email |
namboothiriabhijith27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shifali |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya physiotherapy collage |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9353899352 |
| Fax |
|
| Email |
shifalikotian@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shifali |
| Designation |
Assistant professor |
| Affiliation |
Yenepoya physiotherapy collage |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9353899352 |
| Fax |
|
| Email |
shifalikotian@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| Yenepoya(Deemed to be University),Derlakatte, Mangalore, Karnataka, India - 575018 |
|
|
Primary Sponsor
|
| Name |
Abhijith S Namboothiri |
| Address |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shifali |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Abhijith S Namboothiri |
Yenepoya medical college, 7th floor OPD, physiotherapy department |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018
Dakshina Kannada
KARNATAKA |
08921037554
namboothiriabhijith27@gmail.com |
| Abhijith S Namboothiri |
Yenepoya physiotherapy OPD, 4th floor, Yenepoya ayurvedic medical college, |
Yenepoya physiotherapy college, university road, dertakatte, mangaluru, Dakshina Kannada Karnataka 575018
Dakshina Kannada
KARNATAKA |
8921037554
namboothiriabhijith27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Commitee 3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I629||Nontraumatic intracranial hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CIMT for improve walking speed and maximum step length |
Group A provide intervention of CIMT his conventional training can be defined as intervention without technological resources, using handling, verbal commands, gait training and/or pre-walking activities such as, stepping different direction (forward, backward, side), Ball kicking, Step up on stair, and target achieve activity.
The intervention are used in GroupA are, stepping different direction (forward, backward, side), Ball kicking, Step up on stair, and target achieve activity. Stepping different direction is conducted by therapist by constrain the unaffected leg and maximize the use of affected leg to different directions accordingly. And in Ball kicking activity therapist constrain affected leg and maximize the use of affected leg on standing position, which will improve the balance and the change in range and strength of participants. In step up on stair or stepper by using affected leg free and unaffected will be immobilized and maximize the performance accordingly by improving the gait pattern. And in target activity, therapist place target on floor using different tape and participant follow the instruction accordingly by reach with affected lower limb by constraining the unaffected leg. |
| Comparator Agent |
Theraband assisted walking exercises for improve walking speed and maximum step length |
In Group B, use of the lower extremity elastic strap binding method. According to this study, the knee flexion angle during the stance phase of the patients gait , demonstrating the value of straps in reducing knee hyperextension and the stiff gait pattern of the knee joint that stroke patients experience when walking due to muscular stiffness. This might be because the strap is wrapped over the rear of the injured knee joint, which helps the afflicted side flex its knee. Using an elastic strap that was 5 cm wide, the patient flexed their hips and knees while seated in order to use the Theraband aided walking approach. Placing the midpoint of the strap beneath the affected foot, the therapist crossed it in front of the ankle joint. The strap went up the thigh on the side that was affected when the individual stood, around the back of the knee, and around the back of the lower leg. It passed anteriorly over the thigh and then around the back of the waist before being secured in place.
The exercise giving to the participants in group B are stepping forward, stepping backward, stepping sideways, walked on printed foot print on an even surface. Participants will get Thera-band according to the strength and the height of them. Thera-band will restrict the unwanted movements of lower limb while applying and during the sections of treatments. This will improve the overall gait and angle of each joint on their daily activities.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1. Stroke at least 6 months before study participation.
2. Able to walk at least 10 m with- out aids.
3. Able to move from sitting to standing independently or support of upper limbs
4. Vital signs are stable and there are no other diseases (eg:cardiac issues).
5. Age range: 40–70 years old.
6. Able to sustain body weight on the affected side even without support. |
|
| ExclusionCriteria |
| Details |
1. Patients with severe cognitive impairment who are unable to follow instructions.
2. A visual field defect, problems with the vestibular organ, or an orthopedic medical history of the upper or lower extremity. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.10 meter walk test
2.Gait velocity test
3.Maximum step length test
|
Pre and post Test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
28/11/2025 |
| 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 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
|
Patients who have experienced a stroke and wish to enhance their gait speed and maximum step length make up the study population.Two primary goals were examined in this study. At first will determine wheather assisted thera-band resistance exercises were beneficial for enhancing the gait speed and maximum step length . The other to determine whether the CIMT approach will be beneficial for stroke victims. Twenty-four participants were recruited for the treatment program and split equally into two groups, A and B, consisting of 12 people each. In inclusion criteria, participant with Stroke at least 6 months before study participation, able to walk at least 10 m without aids, able to move from sitting to standing independently or support of upper limbs, vital signs are stable and there are no other diseases (eg:cardiac issues). And patient should be age range of 40–70 years old and patient has able to sustain body weight on the affected side even without support. Moreover patient will be excluded on the basis of, patients with severe cognitive impairment who are unable to follow instructions, visual field defect, problems with the vestibular organ, or an orthopedic medical history of the upper or lower extremity. The whole study conducted on the basis of, all participants were provided with a comprehensive explanation of the study purpose and method and they voluntarily agreed to participate. And patients will be removed from this trial who have two consecutive absences without medical justification and have any clinical intercurrence that makes continuing with the exercises impossible. |