Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001417471
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/10/2025
Date registered
Help: Date registered
16/12/2025
Date last updated
Help: Date last updated
16/12/2025
Date data sharing statement initially provided
Help: Data sharing statement date
16/12/2025
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative efficacy of blood flow restriction training versus conventional strengthening on upper-limb functional capacity and activities of daily living performance after stroke: a randomized clinical trial
Scientific title
A single-blind randomized controlled trial comparing low-load blood flow restriction training and conventional strengthening for upper-limb function and activities of daily living in individuals after stroke
Additional trial identifiers [1] 315615 0
Nill
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Stroke 339282 0
Upper-limb motor impairment 340149 0
Functional disability 340150 0
Condition category
Condition code
Stroke 335544 335544 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 336042 336042 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants performed low-intensity (20–30% of one-repetition maximum) resistance exercises for the affected upper limb under partial vascular occlusion. A pneumatic cuff (10 cm width) applied proximally on the paretic upper arm and inflated to 50% of the individual’s arterial occlusion pressure. Exercises included elbow flexion and extension, wrist flexion and extension, and hand-grip strengthening using dumbbells or elastic bands. Each session consisted of four sets (first set = 30 repetitions; subsequent sets = 15 repetitions) with 30-second inter-set rest periods while the cuff remains inflated. The cuff will be deflated for one minute between exercises. Sessions conducted three times per week for eight consecutive weeks (24 total sessions), each lasting approximately 45–60 minutes, supervised by a physiotherapist. Each patients received one on one treatment. the study was conducted outpatient department of physiotherapy, Ahmad poly clinic, Faisalabad Pakistan.
Intervention code [1] 332238 0
Rehabilitation
Intervention code [2] 332588 0
Treatment: Other
Description of the comparator or control
Participants in the control group will perform the same sequence of exercises without any cuff or occlusion. Exercise intensity will be approximately 60% of one-repetition maximum, performed in three sets of 10–15 repetitions with 60-second rest intervals between sets. Frequency and duration will be identical to the intervention group (three sessions per week for eight weeks).
Control group
Active

Outcomes
Primary outcome [1] 343089 0
Fugl-Meyer Assessment – Upper Extremity (FMA-UE) to assess for motor recovery after stroke
Timepoint [1] 343089 0
Baseline (Week 0 – pre-intervention) and Post-intervention (Week 8 – immediately after program completion)
Secondary outcome [1] 453356 0
essential daily activities of participants through Barthel Index scale to evaluates independence in activities of daily living (ADLs)
Timepoint [1] 453356 0
Assessed at baseline (pre-intervention) and immediately after completion of the 8-week intervention.

Eligibility
Key inclusion criteria
Adults aged 40 to 75 years
First-ever ischemic or hemorrhagic stroke, confirmed by imaging
Duration since stroke 3 to 12 months
Persistent unilateral upper-limb motor deficit with Fugl-Meyer Assessment–Upper Extremity (FMA-UE) score between 15 and 45
Medically stable and cleared by a physician to participate in an exercise program
Able to understand and follow verbal instructions (Mini-Mental State Examination score greater than 24
Willing to provide written informed consent
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Uncontrolled hypertension (resting blood pressure >160/100 mmHg)
Unstable cardiovascular or respiratory disease
Deep vein thrombosis or peripheral vascular disease
Severe spasticity in the affected limb (Modified Ashworth Scale > 2)
Cognitive impairment (Mini-Mental State Examination score < 24)
Active infection, open wounds, or skin lesions proximal to the cuff site
Severe musculoskeletal or orthopedic conditions affecting the upper limb
Participation in other structured rehabilitation or exercise trials within the previous 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered, opaque, sealed envelopes prepared by an independent researcher were used to conceal allocation. The randomization sequence was computer-generated using permuted blocks of four and six, ensuring that group assignments were not predictable prior to participant enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomization sequence was created using permuted blocks of four and six to ensure balanced allocation between groups (1:1 ratio). The randomization list was prepared by an independent researcher not involved in participant recruitment or assessment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/02/2025
Date of last participant enrolment
Anticipated
Actual
10/05/2025
Date of last data collection
Anticipated
Actual
10/08/2025
Sample size
Target
60
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 27456 0
Pakistan
State/province [1] 27456 0
punjab

Funding & Sponsors
Funding source category [1] 320137 0
Self funded/Unfunded
Name [1] 320137 0
Muhammad Abbas, Government College university Faisalabad
Country [1] 320137 0
Pakistan
Funding source category [2] 320217 0
Self funded/Unfunded
Name [2] 320217 0
Ali Husnain, king Edward medical university
Country [2] 320217 0
Pakistan
Primary sponsor type
Individual
Name
Hube Fatima, China medical university,Taichung Taiwan
Address
Country
Taiwan, Province Of China
Secondary sponsor category [1] 323426 0
None
Name [1] 323426 0
Address [1] 323426 0
Country [1] 323426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318683 0
Government College University, Faisalabad, Pakistan
Ethics committee address [1] 318683 0
Ethics committee country [1] 318683 0
Pakistan
Date submitted for ethics approval [1] 318683 0
01/01/2025
Approval date [1] 318683 0
06/01/2025
Ethics approval number [1] 318683 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 144926 0
Dr Ali Husnain
Address 144926 0
Ali Husnain,King Edward Medical University, Lahore, H897+X5V Chowk, Nila Gumbad Rd, Neela Gumbad Lahore, 54000
Country 144926 0
Pakistan
Phone 144926 0
+92 301 7803182
Fax 144926 0
Email 144926 0
[email protected]
Contact person for public queries
Name 144927 0
Hube Fatima
Address 144927 0
China medical university, No. 100, Sec. 1, Jingmao Rd., Beitun Dist., Taichung City 406040, Taiwan R.O.C.
Country 144927 0
Taiwan, Province Of China
Phone 144927 0
+886 989 903 324
Fax 144927 0
Email 144927 0
[email protected]
Contact person for scientific queries
Name 144928 0
Shagufta Jabeen
Address 144928 0
China medical university, No. 100, Sec. 1, Jingmao Rd., Beitun Dist., Taichung City 406040, Taiwan R.O.C.
Country 144928 0
Taiwan, Province Of China
Phone 144928 0
+886 989 903 324
Fax 144928 0
Email 144928 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    updated Ethical letter.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.