Clinical trial NCT06671899: Nineteen Years of Modified CIMT in a Clinical Setting, to Improve Arm and Hand Function After Stroke
Official title: Nineteen Years of Modified Constraint-Induced Movement Therapy in a Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Neurological Diseases or Conditions
Keywords: stroke rehabilitation
physiotherapy
occupational therapy
neurological rehabilitation
upper extremity
CIMT
CI therapy
Lead sponsor: Region Jönköping County
Sponsor class: OTHER_GOV
Collaborators: name: Futurum - Academy for health and care
First posted: 2024-11-04
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients experiencing upper extremity impairments following neurological disorders who underwent a CIMT program at a multidisciplinary rehabilitation medicine clinic in Jönköping, Sweden during the years 2000 and 2018.

Brief summary: The goal of this observational study is to determine if clinically constraint-induced movement therapy (CIMT), when applied in a routine clinical practice, can improve arm- and hand function after stroke. Additionally, the study seeks to identify which patients experienced the greatest improvements, and to examine factors that contribute to the long-term sustainability of the treatment.

Stroke is one leading cause of disability, often resulting in difficulties using the arm and hand function on one side, making daily activities challenging. CIMT aims to enhance arm and hand function after stroke by incorporating intensive training and restraining the non-affected limb, thereby encouraging the use of the affected arm and hand. While numerous studies have demonstrated the effectiveness of CIMT, and it is recommended in national clinical guidelines, it is rarely implemented in clinical practice due to challenges in execution and sustainability. Moreover, it remains unclear which patients benefit the most from the treatment.

At a rehabilitation clinic in Sweden, CIMT has been incorporated into routine care for 19 years, which is uncommon. Participants undergo CIMT as outpatients over a three-week period, with one patient being treated at a time. By retrospectively observe outcomes from this clinically implemented and sustained model of CIMT, the study aims to address the following questions:

* Is CIMT, when conducted in a regular clinical setting, effective?
* Are there relationships between patient characteristics and outcomes?


Eligibility criteria: Inclusion Criteria:

* Post-acute injury (participants had completed primary rehabilitation and were living at home)
* Reduced ability to use the hemi-paretic arm
* Ability to actively extend the metacarpophalangeal and the interphalangeal joints 10°
* Ability to actively extend the wrist 20°

Exclusion Criteria:

* Unable to walk and balance safely without using the non-affected hand, with or without a mobility aid
* Unable to understand the content of the training or lack of motivation
* Serious cognitive deficit or instable medical condition believed to affect training participation
* Pain in the affected arm believed to affect training intensity

Primary outcomes:
measure: The Patient-Specific Functional Scale (PSFS)
timeFrame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
Secondary outcomes:
measure: Motor Activity Log (MAL)
timeFrame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
measure: The Box and Block Test (BBT)
timeFrame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
measure: BL motor assessment
timeFrame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
measure: Active range of motion (AROM)
timeFrame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
measure: Modified Ashworth Scale (MAS)
timeFrame: From start to the end of treatment at 3 weeks, and at follow-up at 6 months.
Other outcomes:
Locations:
city: Jönköping
country: Sweden
facility: Department of Rehabilitation Medicine, Region Jönköping County
Study officials:
affiliation: Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden
name: Kersti Samuelsson, Assoc.Prof.
role: STUDY_CHAIR
References: