Physical DisabilityPASIPD-FrNCT04061616
Transcultural Validation of the Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) in French: The PASIPD-Fr
A study testing PASIPD-Fr in people with Physical Disability and Neurological Diseases or Conditions, run by University Hospital, Caen at 1 site in France.
Trial summary
The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) is a scale that has been developped and validated in English to quantify the level of physical activity for people with physical disabilities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Disability, Neurological Diseases or Conditions
- What is being tested?
- PASIPD-Fr
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2017to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who received research information
- Patient affiliated to a social security system
- Patient over 18 years of age
- Patients with physical disabilities (Act No. 2005-102 on equal rights and opportunities)
- Individuals with the following disease: stroke survivors, multiple sclerosis, neuromuscular disease and idiopathic Parkinson's disease
Who cannot join
- Patient not affiliated to a social security system.
- Patients under guardianship or curators or protection of justice.
- Lack of informed information about the study
- Alteration of higher functions or sensory disturbance making it impossible to understand and adhere to the research protocol
- A severe medical condition that significantly alters functional abilities (severe heart failure, respiratory failure, unstable metabolic disorders such as active renal failure) and involves a life-threatening condition in the short to medium term (progressive neoplastic pathology, unstable systemic disease).
Trial locations and contacts
1 site in 1 country.
About this study
The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) is a scale that has been developped and validated in English to quantify the level of physical activity for people with physical disabilities. The investigators aimed to translate and validate a French transcultural version of the PASIPD (PASIPD-Fr) through a rigourous process following international recommendations for cross-cultural translation and adaptation of questionnaires.
Read the detailed description
For the translation, permission to proceed was obtained, and translation was conducted in consultation with the developers. The investigators proceed to a first translation of the initial scale from English to French with two French native bilingual physicians that resulted in a unique french translation. An English native bilingual physicians proceeded to a back translation from French to English. This version have been sent to the developers who agreed that this back translated version was faithful to the original scale.
For the validation, the investigators used the international recommendations for cross-cultural translation and adaptation of questionnaires. Population was individuals with neurological disease (stroke, multiple sclerosis, Parkinson disease and neuromuscular disorders) with significant in physical disability. Patients were invited in an ambulatory setting. Data collected for every participant included demographic and general variables (age, sex, level, cause and time since neurological disease, walking capacities and aid), scores of a physical performance tests (10 Meter Walking Test, 10 MWT) and the 4 self-administered questionnaires: the Dijon Physical Activity Scale (PAS) the Activities-specific Balance Confidence (ABC) Scale, the Medical Outcome Study Short Form 12 " (MOS SF-12) and the Hospital Anxiety and Depression (HAD) scale.
Face validity was assessed using verbal feedbacks from physician and patients, and the mean time to fill-out the scale.
Criterion validity was assessed with correlation and discrimination analysis between the scores for the PASIPD-Fr and the Dijon PAS.
Construct validity was assessed using the correlation with scores of instruments that measure various aspects related to and physical activity (convergent validity) such as the self-reported questionaires ABC, SF-12 and HAD scales and also the 10 MWT.
For consistency and reliability, the investigators calculated the Cronbach α coefficient and calculated the ICC between 2 completions at a 2-week interval.
Sample calculation was based on an expected ICC > 0.9, which required 50 participants to reject the hypothesis that the actual ICC is < 0.6, which corresponds to the lower limit for a "good" reproducibility.
- Being tested
- PASIPD-Fr
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASIPD-FrBehavioural
Fill-out the PASIPD-Fr self questionaire twice (2 completions at a 2-week interval)
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | All the participants volunteer to participate to the study that were included. Receives: Behavioral: PASIPD-Fr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Criterion validity (correlation)
The Dijon PAS assesses the level of physical activity in the general population, the elderly and is recommended after a stroke. To test the criterion validity of the PASIPD-Fr, the investigators calculated the Pearson correlation coefficient (PCC) between the scores for the PASIPD-Fr and the Dijon PAS.
Measured: Both scales (PASIPD-Fr and Dijon PAS) were filled-out in a single point of time within a period of time of 12 months (study time frame)
Criterion validity (discrimination)
The Dijon PAS assesses the level of physical activity in the general population, the elderly and is recommended after a stroke. To test the criterion validity of the PASIPD-Fr, the investigators used the repeated measures ANOVA to check for differences between inactive, moderately active ang highly active individuals (respectively score <10, 10-20 and >20 over 30 on Dijon PAS) with Tukey post-hoc tests.
Measured: Both scales (PASIPD-Fr and Dijon PAS) were filled-out in a single point of time within a period of time of 12 months (study time frame)
Test-retest reliability
The investigators calculated the intraclass coefficient (ICC) between 2 completions of the PASIPD-Fr questionnaire at a 2-week interval.
Measured: The PASIPD-Fr was administered twice at a 2-week interval within a period of time of 12 months (study time frame)
Secondary outcomes (5)
Construct validity 10TMWT
The 10 Meter Walk Test is is a performance measure used to assess walking speed in metres per second over a short distance.To test the criterion validity of the PASIPD-Fr, the investigators calculated the Pearson correlation coefficient (PCC) between the scores for the PASIPD-Fr and the 10MWT
Measured: Both PASIPD-Fr questionaire and 10MWT test were assessed in a single point of time within a period of time of 12 months (study time frame)
Construct validity ABC-S
The Activities-specific balance confidence (ABC) scale is a subjective measure of confidence in performing various ambulatory activities without experiencing a sense of unsteadiness.To test the criterion validity of the PASIPD-Fr, the investigators calculated the Pearson correlation coefficient (PCC) between the scores for the PASIPD-Fr and the ABC-S
Measured: Both PASIPD-Fr questionaire and ABC-S scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
Construct validity HAD
The Hospital Anxiety and Depression scale (HAD) is used to determine the levels of anxiety and depression that a person is experiencing. To test the criterion validity of the PASIPD-Fr, the investigators calculated the Pearson correlation coefficient (PCC) between the scores for the PASIPD-Fr and the HAD
Measured: Both PASIPD-Fr questionaire and HAD scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
Construct validity MOS SF12
The Medical Outcome Study Short Form 12 " (MOS SF-12) is used to measure mental and physical health. To test the criterion validity of the PASIPD-Fr, the investigators calculated the Pearson correlation coefficient (PCC) between the scores for the PASIPD-Fr and the MOS SF12
Measured: Both PASIPD-Fr questionaire and MOS SF12 scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
Internal consistency
To measure the internal consistency (homogeneity) of the PASIPD-Fr, based on average inter-item correlations and the number of items.
Measured: The PASIPD-Fr scale was filled-out in a single point of time within a period of time of 12 months (study time frame)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start1 Jul 2017
- Primary completion1 Feb 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061616
- Sponsor's protocol ID
- PASIPD-Fr
- Acronym
- PASIPD-Fr
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Meunier P, Joussain C, Gremeaux V, Carnet D, Bastable P, Ruet A, Drigny J. Transcultural adaptation and validation of a French version of the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD-Fr). Ann Phys Rehabil Med. 2021 Jul;64(4):101423. doi: 10.1016/j.rehab.2020.07.006. Epub 2020 Aug 26. No abstract available.
PubMed 32763488
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural Validation of the Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) in French: The PASIPD-Fr
- ClinicalTrials.gov ID
- NCT04061616
- Acronym / sponsor ID
- PASIPD-Fr / PASIPD-Fr
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Physical Activity Scale for Individuals With Physical Disabilities (PASIPD) is a scale that has been developped and validated in English to quantify the level of physical activity for people with physical disabilities. The investigators aimed to translate and validate a French transcultural version of the PASIPD (PASIPD-Fr) through a rigourous process following international recommendations for cross-cultural translation and adaptation of questionnaires.
Detailed description
For the translation, permission to proceed was obtained, and translation was conducted in consultation with the developers. The investigators proceed to a first translation of the initial scale from English to French with two French native bilingual physicians that resulted in a unique french translation. An English native bilingual physicians proceeded to a back translation from French to English. This version have been sent to the developers who agreed that this back translated version was faithful to the original scale.
For the validation, the investigators used the international recommendations for cross-cultural translation and adaptation of questionnaires. Population was individuals with neurological disease (stroke, multiple sclerosis, Parkinson disease and neuromuscular disorders) with significant in physical disability. Patients were invited in an ambulatory setting. Data collected for every participant included demographic and general variables (age, sex, level, cause and time since neurological disease, walking capacities and aid), scores of a physical performance tests (10 Meter Walking Test, 10 MWT) and the 4 self-administered questionnaires: the Dijon Physical Activity Scale (PAS) the Activities-specific Balance Confidence (ABC) Scale, the Medical Outcome Study Short Form 12 " (MOS SF-12) and the Hospital Anxiety and Depression (HAD) scale.
Face validity was assessed using verbal feedbacks from physician and patients, and the mean time to fill-out the scale.
Criterion validity was assessed with correlation and discrimination analysis between the scores for the PASIPD-Fr and the Dijon PAS.
Construct validity was assessed using the correlation with scores of instruments that measure various aspects related to and physical activity (convergent validity) such as the self-reported questionaires ABC, SF-12 and HAD scales and also the 10 MWT.
For consistency and reliability, the investigators calculated the Cronbach α coefficient and calculated the ICC between 2 completions at a 2-week interval.
Sample calculation was based on an expected ICC > 0.9, which required 50 participants to reject the hypothesis that the actual ICC is < 0.6, which corresponds to the lower limit for a "good" reproducibility.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Behavioral: PASIPD-FrAll the participants volunteer to participate to the study that were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient who received research information
- Patient affiliated to a social security system
- Patient over 18 years of age
- Patients with physical disabilities (Act No. 2005-102 on equal rights and opportunities)
- Individuals with the following disease: stroke survivors, multiple sclerosis, neuromuscular disease and idiopathic Parkinson's disease
Key exclusion criteria (5 listed)
- Patient not affiliated to a social security system.
- Patients under guardianship or curators or protection of justice.
- Lack of informed information about the study
- Alteration of higher functions or sensory disturbance making it impossible to understand and adhere to the research protocol
- A severe medical condition that significantly alters functional abilities (severe heart failure, respiratory failure, unstable metabolic disorders such as active renal failure) and involves a life-threatening condition in the short to medium term (progressive neoplastic pathology, unstable systemic disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASIPD-FrFill-out the PASIPD-Fr self questionaire twice (2 completions at a 2-week interval) | Behavioural | Participants |
Primary outcome
Criterion validity (correlation)
Time frame: Both scales (PASIPD-Fr and Dijon PAS) were filled-out in a single point of time within a period of time of 12 months (study time frame)
The Dijon PAS assesses the level of physical activity in the general population, the elderly and is recommended after a stroke. To test the criterion validity of the PASIPD-Fr, the investigators calculated the Pearson correlation coefficient (PCC) between the scores for the PASIPD-Fr and the Dijon PAS.
Criterion validity (discrimination)
Time frame: Both scales (PASIPD-Fr and Dijon PAS) were filled-out in a single point of time within a period of time of 12 months (study time frame)
The Dijon PAS assesses the level of physical activity in the general population, the elderly and is recommended after a stroke. To test the criterion validity of the PASIPD-Fr, the investigators used the repeated measures ANOVA to check for differences between inactive, moderately active ang highly active individuals (respectively score <10, 10-20 and >20 over 30 on Dijon PAS) with Tukey post-hoc tests.
Test-retest reliability
Time frame: The PASIPD-Fr was administered twice at a 2-week interval within a period of time of 12 months (study time frame)
The investigators calculated the intraclass coefficient (ICC) between 2 completions of the PASIPD-Fr questionnaire at a 2-week interval.
5 secondary outcomes
Construct validity 10TMWT
Time frame: Both PASIPD-Fr questionaire and 10MWT test were assessed in a single point of time within a period of time of 12 months (study time frame)
Construct validity ABC-S
Time frame: Both PASIPD-Fr questionaire and ABC-S scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
Construct validity HAD
Time frame: Both PASIPD-Fr questionaire and HAD scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
Construct validity MOS SF12
Time frame: Both PASIPD-Fr questionaire and MOS SF12 scale were filled-out in a single point of time within a period of time of 12 months (study time frame)
Internal consistency
Time frame: The PASIPD-Fr scale was filled-out in a single point of time within a period of time of 12 months (study time frame)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Results publication: PubMed 32763488Meunier P, Joussain C, Gremeaux V, Carnet D, Bastable P, Ruet A, Drigny J. Transcultural adaptation and validation of a French version of the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD-Fr). Ann Phys Rehabil Med. 2021 Jul;64(4):101423. doi: 10.1016/j.rehab.2020.07.006. Epub 2020 Aug 26. No abstract available.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASIPD-Fr in people with Physical Disability and Neurological Diseases or Conditions, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Criterion validity (correlation) (time frame: Both scales (PASIPD-Fr and Dijon PAS) were filled-out in a single point of time within a period of time of 12 months (study time frame)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04061616, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.