Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202507883937004 Date of Registration: 10/07/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluating Rehabilitation outcomes and related factors for stroke survivors at a private rehabilitation centre in Eastern Cape: a cohort study
Official scientific title Evaluating Rehabilitation outcomes and related factors for stroke survivors at a private rehabilitation centre in Eastern Cape: a cohort study
Brief summary describing the background and objectives of the trial Stroke is a significant cause of long-term disability in South Africa, with substantial socioeconomic and healthcare impacts. The Eastern Cape region encounters specific challenges in stroke care and rehabilitation due to its demographic and resource context. While more stroke survivors are accessing private rehabilitation services, there is limited evidence on their recovery progress and the factors influencing outcomes. This study aims to investigate rehabilitation outcomes and related factors at a private rehabilitation facility in the Eastern Cape. An observational cohort study will be conducted at a rehabilitation centre, where participants' impairment (lower limb weight bearing) will be measured using a digital scale at both admission and discharge over a six-week period. Data collection includes mood and functional assessments using SIS, FIM, and SS-QOL. These assessments will be conducted at admission and discharge. This study aims to enhance rehabilitation strategies by offering physiotherapists and other multidisciplinary team members valuable insights into effective approaches for improving functional outcomes. The goal is to align clinical assessments with patient-reported experiences, thereby enhancing the quality of life (QoL) for stroke survivors. By achieving this alignment, the study seeks to foster better functional outcomes for individuals recovering from a stroke.
Type of trial Observational
Acronym (If the trial has an acronym then please provide) NA
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 18/08/2025
Actual trial start date 01/12/2025
Anticipated date of last follow up 02/01/2026
Actual Last follow-up date 27/02/2026
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group evaluating rehabilitation outcomes post stroke participants will be receiving physiotherapy sessions daily 45-60minutes 6 weeks This study will be conducted in the rehabilitation centre in Eastern Cape. Patients will be tested on rehabilitation outcomes (FIM, SIS WB and QOL) and related factors (social, environmental/ emotional). Digital scale for lower limb weight bearing will be used at admission and discharge over the rehabilitation period (4-6 weeks). Functional independence measure and SIS will be done to assess function and emotional domain of participants on admission and discharge. Health related quality of life using SS-QoL at admission and discharge. Participants will continue with standard rehabilitation (physiotherapy, occupational therapy, speech therapy as needed). 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who are medically stable as medically unstable patients may have conditions such as uncontrolled hypertension, cardiac instability, or deep vein thrombosis (DVT), which could increase the risk of adverse events during weight bearing activities during the rehabilitation phase. Also, stroke patients who are medically stable are more likely to tolerate and engage well in therapy, leading to more accurate assessments of weight-bearing. Participants who achieve a score between 19-24 out of 30 on the Mini-Mental State Examination (MMSE) for cognitive function, indicating mild impairment to normal cognition Participants who have had multiple strokes, as they may have already developed secondary complications. Adult: 18 Year(s)-44 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 18/08/2025 The Faculty of Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Hatfield Pretoria Pretoria 0028 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • To evaluate impairment (lower limb weight bearing), function (Functional Independence Measure-FIM) and) and participation (Stroke Impact scale-SIS and the Stroke Specific (SS) -QoL for HRQoL) outcomes (FIM/SIS/WB/QoL) for stroke survivors at a private rehabilitation centre upon admission and discharge. • To evaluate stroke-related factors (type of stroke, site of lesion, side of stroke) for stroke survivors at a private rehabilitation centre upon admission and discharge • To correlate the rehabilitation outcomes (FIM/SIS/LL SS-QoL) with stroke-related factors for stroke survivors at a private rehabilitation centre All the outcome measures will be assessed on week 1 of admission and on discharge week 6 in the rehabilitation Centre.
Secondary Outcome To correlate the rehabilitation outcomes (FIM/SIS/LL SS-QoL) with stroke-related factors for stroke survivors at a private rehabilitation centre. Stroke-specific QoL will be assessed on week 1 admission and week 6 discharge at the rehabilitation centre
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nurture Health Beacon Bay 8 st Helena road Beacon Bay Eastern Cape 5241 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Sinazo Christian 59 main road Gonubie East London 5256 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sinazo Christian 59 main road Gonubie East London 5256 South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sinazo Christian sinazochristian@gmail.com 0649037333 59 main road Gonubie
City Postal code Country Position/Affiliation
East London 5256 South Africa Physiotherapist
Role Name Email Phone Street address
Public Enquiries Pooveshni Naidoo pooveshni.naidoo@up.ac.za 0789095934 Pretoria
City Postal code Country Position/Affiliation
Pretoria 0001 South Africa Research Supervisor
Role Name Email Phone Street address
Scientific Enquiries Heleen Nel vanwyk@ufs.ac.za 0828293550 Bloemfontein
City Postal code Country Position/Affiliation
Bloemfontein 9300 South Africa Cosupervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The participants will have study numbers so that they cannot be identified. The numbers will be confidential and only known to the researcher and the supervisors. Only the researcher and the supervisors will have access to usernames and passwords. De-identified data will be shared: Demographic details: sex, age, type of stroke and side of stroke. Rehabilitation outcomes measures: FIM scores, weight-bearing measures and mood questionnaires Informed Consent Form,Study Protocol The data will be shared 6 months after the completion of the study. The data will be available for 15 years as per the University of Pretoria's requirements. Access to the data will be controlled. Data will be shared with researchers, clinicians or institutions conducting studies related to stroke rehabilitation, mobility, function and weight-bearing post-stroke with a valid proposal and ethical approval. Data will be shared for secondary analysis, meta-analysis and further evaluation and rehabilitation outcomes. Data requests can be sent to the principal investigator. Access will be granted after review of requests by the study's data access committee. Data will be shared via a secure password-protected repository (e.g. University email).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/07/2025 Added more information for clarity Experimental Group, evaluating rehabilitation outcomes post stroke, participants will be receiving physiotherapy sessions daily 45-60minutes , 6 weeks, This study will be conducted in the rehabilitation centre in Eastern Cape. Patients will be tested on rehabilitation outcomes (FIM, SIS WB and QOL) and related factors (social, environmental/ emotional). Digital scale for lower limb weight bearing will be used at admission and discharge over the rehabilitation period (4-6 weeks). Functional independence measure and SIS will be done to assess function and emotional domain of participants on admission and discharge. Health related quality of life using SS-QoL at admission and discharge. Participants will continue with standard rehabilitation (physiotherapy, occupational therapy, speech therapy as needed)., 30,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/07/2025 Added more clarity on time points Primary Outcome, • To evaluate impairment (lower limb weight bearing), function (Functional Independence Measure-FIM) and) and participation (Stroke Impact scale-SIS and the Stroke Specific (SS) -QoL for HRQoL) outcomes (FIM/SIS/WB/QoL) for stroke survivors at a private rehabilitation centre upon admission and discharge. • To evaluate stroke-related factors (type of stroke, site of lesion, side of stroke) for stroke survivors at a private rehabilitation centre upon admission and discharge • To correlate the rehabilitation outcomes (FIM/SIS/LL SS-QoL) with stroke-related factors for stroke survivors at a private rehabilitation centre , FIM to be measured on week 1 and week 6. Stroke impact scale to be done on week 1 and week 6. Stroke specific quality of life to be done at week 1 and week 6 Primary Outcome, • To evaluate impairment (lower limb weight bearing), function (Functional Independence Measure-FIM) and) and participation (Stroke Impact scale-SIS and the Stroke Specific (SS) -QoL for HRQoL) outcomes (FIM/SIS/WB/QoL) for stroke survivors at a private rehabilitation centre upon admission and discharge. • To evaluate stroke-related factors (type of stroke, site of lesion, side of stroke) for stroke survivors at a private rehabilitation centre upon admission and discharge • To correlate the rehabilitation outcomes (FIM/SIS/LL SS-QoL) with stroke-related factors for stroke survivors at a private rehabilitation centre , All the outcome measures will be assessed on week 1 of admission and on discharge week 6 in the rehabilitation Centre.
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 04/07/2025 Specified time points Secondary Outcome, To correlate the rehabilitation outcomes (FIM/SIS/LL SS-QoL) with stroke-related factors for stroke survivors at a private rehabilitation centre , Stroke specific quality of life to be assessed on week 1 and week 6 Secondary Outcome, To correlate the rehabilitation outcomes (FIM/SIS/LL SS-QoL) with stroke-related factors for stroke survivors at a private rehabilitation centre. , Stroke-specific QoL will be assessed on week 1 admission and week 6 discharge at the rehabilitation centre
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 04/07/2025 Updated missing information No funding, 59 main road Gonubie, East London, 5256, South Africa, Self Funded, Principal investigator, 59 main road Gonubie, East London, 5256, South Africa, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 04/07/2025 Updated missing information Principal investigator, 59 main road Gonubie, East London, 5256, South Africa, Self Funded, Sinazo Christian, 59 main road Gonubie, East London, 5256, South Africa, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 10/07/2025 Correct information added The Target Audiences for this study include clinical practitioners, rehabilitation centres, stroke survivors and caregivers, academic and research communities. Academic Dissemination: • Peer-reviewed Journal Publication • Internal in-service training: Presentations at the participating rehabilitation centre to inform clinical staff of the findings and implications for practice • The findings will be disseminated through articles published in both local and international journals. Additionally, the information will be presented at a congress and Faculty Day at UP. The participants will have study numbers so that they cannot be identified. The numbers will be confidential and only known to the researcher and the supervisors. Only the researcher and the supervisors will have access to usernames and passwords. De-identified data will be shared: Demographic details: sex, age, type of stroke and side of stroke. Rehabilitation outcomes measures: FIM scores, weight-bearing measures and mood questionnaires
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 10/07/2025 Correct information added 2 years The data will be shared 6 months after the completion of the study. The data will be available for 15 years as per the University of Pretoria's requirements.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 10/07/2025 Correct information added Controlled Access to the data will be controlled. Data will be shared with researchers, clinicians or institutions conducting studies related to stroke rehabilitation, mobility, function and weight-bearing post-stroke with a valid proposal and ethical approval. Data will be shared for secondary analysis, meta-analysis and further evaluation and rehabilitation outcomes. Data requests can be sent to the principal investigator. Access will be granted after review of requests by the study's data access committee. Data will be shared via a secure password-protected repository (e.g. University email).