Comparison of the Effectiveness of an Adapted Physical Activity Program in a Dedicated Structure to a Self-program in Patients in Chronic Phase of a Stroke

Stroke Clinical Trial

— StrokAPA  

Official title:

Comparison of the Effectiveness of an Adapted Physical Activity Program in a Dedicated Structure to a Self-program in Patients in Chronic Phase of a Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06061770
• Other study ID #: RCAPHM21_0439
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: June 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Maeva COTINAT
• Phone: 04 91 74 42 00
• Email: maeva.cotinat[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized, controlled, two parallel arms, single-blind pilot study. In this design, all included patients in the chronic phase of a stroke will receive both modes of physical activity.

This study includes patients over 18 years of age with spastic hemiparesis sequelae of a first unilateral hemispheric stroke older than 6 months and able to walk for 6 minutes. The non-inclusion criteria were the inability to walk without human assistance (with or without technical aids), the existence of cognitive disorders compromising informed consent, in particular the inability to understand the objective and the modalities of the protocol, the inability to communicate with the examiners, and the presence of an additional neurological disorder or a pathology contraindicating the practice of physical activity.

The primary endpoint is based on daily activity measurement by measuring the number of steps per day, collected over the duration of the study, via a Stepwatch™ device. Secondary end points involve a written physical activity report, assessment of walking ability (via walking-test 6, heart rate, and blood pressure), a measure of perceived exertion, stroke-specific quality of life, balance, and motivation to perform physical activity.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age greater than 18 years

• Left or right spastic hemiparesis after a first hemorrhagic or ischemic unilateral stroke older than 6 months

• Walking possible for 6 minutes

Exclusion Criteria:

• Inability to walk without human assistance (with or without technical aids)

• Cognitive impairment that compromises informed consent, including inability to understand the purpose and terms of the protocol

• Inability to communicate

• Presence of an additional neurological disorder

• Medical conditions that contraindicate physical activity, such as an unbalanced cardiovascular or respiratory condition

• Concurrent participation in another clinical research project

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Adapted physical activity program
Rehabilitation
• Adapted physical activity self-program
Rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily activity measurement	Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device	through study completion
Secondary	the rate physical activities in Written report	carried out by the patient, more or less helped by his close entourage, recorded in a notebook given at the beginning of the study	through study completion
Secondary	6-minute walk test (6MWT)	A test validated in the literature that consists of measuring the greatest distance that a subject can travel on a flat surface (30 meter corridor) in 6 minutes.	at inclusion Day and at the 13th week (and the 26th week for one group only)
Secondary	Measurement of heart rate at rest and after 6-minute walk test	with a blood pressure cuff	at inclusion Day and at the 13th week (and the 26th week for one group only)
Secondary	Measurement of systolic blood pressure at rest and after 6-minute walk test	with a blood pressure cuff	at inclusion Day and at the 13th week (and the 26th week for one group only)
Secondary	Borg Rating Scale of Exertion	test validated in the literature that allows the evaluation of the perception of effort by the patient ; minimum value : 0 = rest : no exertion ; maximum value : 10 = maximal exertion	at inclusion Day and at the 13th week (and the 26th week for one group only)
Secondary	Stroke Specific Quality of Life scale (SS-QoL)	A test validated in French in the literature that assesses the specific quality of life of stroke patients in 49 items ; minimum value : 1 = Total help/ Couldn't do it at all/ Strongly agree ; maximum value : 5 = No help needed/ No trouble at all/ Strongly disagree	at inclusion Day and at the 13th week (and the 26th week for one group only)
Secondary	Berg Balance Scale (BBS)	validated scale allowing, by means of 14 instructions, an evaluation of balance, reproducible and sensitive to change ; minimum score : 0-20 = high risk of falling ; maximal score : 56 = no risk of falling	at inclusion Day and at the 13th week (and the 26th week for one group only)
Secondary	Activity-specific Balanced Confidence scale (ABC scale)	French language validated scale assessing the patient's confidence in his or her balance, using 16 situations where the subject is asked to rate his or her balance on a numerical scale ; minimal rate : 0% = not at all confident ; maximal rate : 100% = completely confident	at inclusion Day and at the 13th week (and the 26th week for one group only)
Secondary	Behavioral regulation in exercise questionnaire	scale used in the literature to assess motivation to perform physical activity ; minimal value : 1 = not true at all ; maximal value : 7 = absolutely true	at inclusion Day and at the 13th week (and the 26th week for one group only)