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CTRI Number  CTRI/2025/08/093574 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
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 Study Comparing Physiotherapy and Ankle Foot Orthosis (AFO) for Improving Walking in Stroke Patients 
Scientific Title of Study   Compare the Efficacy between Conventional Physiotherapy and Unilateral Ankle Foot Orthosis (AFO) among Patients with Stroke Suffering from Gait Dysfunction 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nasrin Akther Munmun 
Designation  Undergraduate Student 
Affiliation  Bangladesh Health Professions Institute (BHPI) 
Address  Department of Physiotherapy, Bangladesh Health Professions Institute (BHPI), CRP, Savar



1343
Other 
Phone  8801740422979  
Fax    
Email  nasrinakther141032@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Habibur Rahman 
Designation  Assistant Professor 
Affiliation  Bangladesh Open University (BOU) 
Address  Department of masters of disability management and rehabilitation program, Bangladesh Open University (BOU), Board bazar, Gazipur



1705
Other 
Phone  8801919902188  
Fax    
Email  drsumonptbou@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohammad Habibur Rahman 
Designation  Assistant Professor 
Affiliation  Bangladesh Open University (BOU) 
Address  Department of masters of disability management and rehabilitation program, Bangladesh Open University (BOU), Board bazar, Gazipur



1705
Other 
Phone  8801919902188  
Fax    
Email  drsumonptbou@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Prof Md Obaidul Haque 
Address  Room:1, Department of Physiotherapy, Bangladesh Health Professions Institute (BHPI) 
Type of Sponsor  Other [Bangladesh Health Professions Institute (BHPI)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Dr Mohammad Anwar Hossain  Centre for the rehabilitation of the paralysed (CRP)  Room: Neuro 1,2 Department of physiotherapy, Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka, Bangladesh

 		 8801730059633

anwar_physiobd@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Review Board (IRB) of BHPI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional Physiotherapy  Postural control (5-10 min 10 rep)Synergic movement practice (5-10 min 10 rep) Proper positioning practice(5-10 min 10 rep) Muscle activation (3-4 min) Stretching(6-8 min) Soft Tissue Techniques (5 min 3-5 rep) Exercises in Lower Initial Positions (3-5 min 10 rep) Upper-Limb/Trunk Exercises While Sitting (5-10 min) Hand Exercises – Scapular setting, rhythmic hand movement practice (5-10 min) Lower-Limb Exercises While Sitting – pelvic tilting and anterior lateral pelvic shifting (5-10 min 10 rep) Transfer Exercises (10-15 min) Exercises While Standing (10-15 min) Gait on Even Floor (10-15 min) Steeping(5 min 20 rep) Stairs (5-7 min) Gait on Uneven Ground(10-20 min) The total duration of intervention will be 45 min 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  31.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Post-stroke patients diagnosed with unilateral hemiparesis secondary to cerebrovascular accident (CVA)

Duration of stroke between 6 to 12 months

Severe weakness of ankle dorsiflexor on the affected side

Ability to stand independently for at least 1 minute

Ability to walk a distance of 10 meters with or without assistive devices

No history of orthopedic problems affecting the lower extremities

Male and female patients diagnosed with CVA

Ability to comprehend and follow instructions related to the testing procedure 
 
ExclusionCriteria 
Details  Patients with bilateral stroke

Patients with cognitive or perceptual dysfunction

Uncooperative or non-compliant patients

Presence of mental health conditions interfering with participation

Visual or auditory impairments that could affect gait assessment

Orthopedic disorders of the lower limbs that impair ambulation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Gait parameter measurement for measuring the speed, step length, stride length and cadence  Base line- after 8 weeks- after 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time Up and Go test for mobility
2. 6 min walk test for functional exercise capacity 		 Base line- after 8 weeks- after 8 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsumonbou@gmail.com].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The purpose of the pre-experimental study was to compare the efficacy between conventional physiotherapy and unilateral ankle foot orthosis among stroke patients suffering from gait dysfunction. For that reasons 20 participants are assign to measure the TUG, 6MWT and Gait parameters which are used to measure the effectiveness of both conventional physiotherapy and unilateral AFO. The study shows significant difference within levels and it highlights that Post-test 2 is more significant that pre-test and post -test 1. 
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