| CTRI Number |
CTRI/2024/03/064402 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Exploring the Transformative Effects of Reverse Walking Training on Functional Balance and Gait Velocity in Stroke Survivors |
|
Scientific Title of Study
|
The Impact Of Reverse Walking Training On Functional
Balance And Gait Velocity In Individuals With A
Diagnosis Of Stroke |
| 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 MEENA GUPT |
| Designation |
Assistant Professor, Amity Institute of Health Allied Sciences |
| Affiliation |
AMITY UNIVERSITY |
| Address |
LG21 Research Lab, Department of Physiotherapy, Amity University, Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
918929286943 |
| Fax |
|
| Email |
Mgupta9@amity.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Meena gupta |
| Designation |
Assistant Professor, Amity Institute of Health Allied Sciences |
| Affiliation |
AMITY UNIVERSITY |
| Address |
J1 Block (AIBHAS) 2nd floor, Amity University Noida, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
918929286943 |
| Fax |
|
| Email |
Mgupta9@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Shivam Yadav |
| Designation |
PG STUDENT,Amity Institute of Health Allied Sciences |
| Affiliation |
AMITY UNIVERSITY |
| Address |
J1 Block (AIBHAS) 2nd floor, Amity University Noida, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201303
India |
| Phone |
918929286943 |
| Fax |
|
| Email |
Shivamyad611@gmail.com |
|
|
Source of Monetary or Material Support
|
| SPES Super Speciality Hospital,Pari Chowk, NRI City, Omega II, Noida, Greater Noida, Uttar Pradesh 201310 |
|
|
Primary Sponsor
|
| Name |
SPES Super Speciality Hospital |
| Address |
Pari Chowk, NRI City, Omega II, Noida, Greater Noida, Uttar Pradesh 201310 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 MEGHA GAUR |
SPES HOSPITAL |
Room number 6,Department Of Physiotherpy, Pari Chowk, NRI City, Omega II, Noida, Greater Noida, Uttar Pradesh 201310
Gautam Buddha Nagar
UTTAR PRADESH |
9720877855
Meghagaur2909@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Amity Institute of Health Allied Sciences, Amity University Uttar Pradesh |
Approved |
| SPES Hospital |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Reverse walking training |
Intervention Group (Experimental): Reverse Walking Training
Supervised sessions will be conducted by trained rehabilitation professionals.
Initial assessment of baseline functional balance and gait velocity will be performed.
Reverse walking training will be conducted on a treadmill or in a controlled indoor environment.
Sessions will gradually increase in intensity and duration over the intervention period.
Training frequency will be determined based on individual tolerance and progression goals.
Each session will include warm-up, main exercise (reverse walking), and cool-down periods.
Progress will be monitored regularly, with adjustments made to the training program as needed.
Adherence to the protocol and safety measures will be closely monitored. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 years or older.
2. Individuals diagnosed with a stroke, either ischemic or haemorrhagic.
3. The stroke event occurred at least 6 months before the study.
4. Participants with mild to moderate impairments in balance and gait, as
determined by standardized assessment tools (e.g., Berg Balance Scale,
Timed Up and Go test).
5. Able to walk independently or with minimal assistance (e.g., assistive
devices such as canes or walkers).
6. Medically stable and cleared for participation in physical activities by a
healthcare professional.
7. Willingness to participate in a structured reverse walking training program
for the duration of the study.
8. Ability to follow instructions and provide informed consent for
participation.
|
|
| ExclusionCriteria |
| Details |
1. Severe cognitive impairments or inability to understand and follow
instructions necessary for the reverse walking training program.
2. Severe physical disabilities or comorbidities that prevent participation in
physical activities or the reverse walking training program.
3. Uncontrolled medical conditions that may pose a risk during the training
program (e.g., uncontrolled hypertension, cardiac conditions).
4. Recent history of lower extremity surgery or injury that may affect balance
or gait performance.
5. History of other neurological conditions or impairments that may
significantly influence balance or gait abilities, independent of the stroke
diagnosis.
6. Presence of unhealed wounds or skin ulcers that may be aggravated or
worsened during the training program.
7. Pregnancy, as the training program may pose potential risks to the
participant and the unborn child.
8. Inability or unwillingness to provide informed consent for participation. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional Balance Improvement:
Measure: Berg Balance Scale (BBS)
Criteria: Changes in BBS scores from baseline to post-intervention. |
baseline, 4 weeks & 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Long-Term Effects:
Comparison with Conventional Rehabilitation:Implications for Rehabilitation Protocols:
|
baseline, 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/03/2024 |
| 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="1"
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
|
1. Recruitment and Screening: Participants meeting the inclusion criteria would be recruited from stroke rehabilitation centres or outpatient clinics. They would undergo a screening process to confirm their eligibility for the study. Informed consent would be obtained from all participants. 2. Baseline Assessment: Before the intervention, baseline assessments of functional balance and gait velocity would be conducted using standardized tools such as the Berg Balance Scale, Timed Up and Go test, 10-Meter Walk Test, and/or other relevant measures. Additional demographic and clinical data may also be collected. 3. Randomization and Group Allocation: Participants would be randomly assigned to either the experimental group or the control group using an appropriate randomization method. Group allocation would be concealed from both the researchers and the participants, whenever possible. 4. Experimental Group - Reverse Walking Training: Participants in the experimental group would undergo a structured reverse walking training program. The training program would consist of exercises and tasks specifically designed to challenge balance, coordination, and gait patterns in a backward walking direction. The duration, frequency, and intensity of the training sessions would be predetermined and standardized for all participants in this group. 5. Control Group - Standard Care or Placebo Intervention: Participants in the control group would receive standard care or a placebo intervention that does not specifically target balance or gait. This could involve usual rehabilitation therapies or activities that do not directly impact functional balance and gait. 6. Monitoring and Progress Evaluation: Throughout the study period, participants’ progress and adherence to the intervention will be monitored. Any adverse events or side effects would be documented and addressed accordingly. 7. Post-intervention Assessment: After the intervention period, a post-intervention assessment of functional balance and gait velocity will be conducted using the same standardized assessment tools as in the baseline assessment. This allows for a comparison of outcomes between the experimental and control groups. 8. Data Analysis: The collected data would be analysed using appropriate statistical methods to assess the impact of reverse walking training on functional balance and gait velocity. Statistical tests such as t-tests, ANOVA, or non-parametric equivalents would be used to determine any significant differences between the experimental and control groups. 9. Results and Conclusion: The findings will be interpreted, and conclusions will be drawn regarding the impact of reverse walking training on functional balance and gait velocity in individuals with a diagnosis of stroke. The study’s limitations and implications for future research or clinical practice will also be discussed |