Nineteen Years of Modified CIMT in a Clinical Setting, to Improve Arm and Hand Function After Stroke

NCT06671899 | Completed

• 1 other identifier: 2019-02250
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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?

Conditions

Stroke; Neurological Diseases or Conditions

Keywords

stroke rehabilitation; physiotherapy; occupational therapy; neurological rehabilitation; upper extremity; CIMT; CI therapy

Outcome Measures

Primary Outcomes (1)

• The Patient-Specific Functional Scale (PSFS)

  The Patient-Specific Functional Scale is a self-reporting tool meticulously designed to capture and document activity performance challenges identified as significant by the patient. The patients rate their performance on a numeric rating scale from 0 to 10 (0, unable to perform activity; 10, able to perform activity without difficulties or at pre-injury level). In this study, patients autonomously selected 1-5 activities aligned with their personal goals and rated their performance using the PSFS (a mean score for the self-identified activities was labelled PSFS-self). Additionally, patients assessed a single predetermined activity, namely eating with a knife and fork; which was included in the exercise programme for all patients on a daily basis (labelled PSFS-KF).

  From start to the end of treatment at 3 weeks, and at follow-up at 6 months.

Secondary Outcomes (5)

• Motor Activity Log (MAL)

  From start to the end of treatment at 3 weeks, and at follow-up at 6 months.

• The Box and Block Test (BBT)

  From start to the end of treatment at 3 weeks, and at follow-up at 6 months.

• BL motor assessment

  From start to the end of treatment at 3 weeks, and at follow-up at 6 months.

• Active range of motion (AROM)

  From start to the end of treatment at 3 weeks, and at follow-up at 6 months.

• Modified Ashworth Scale (MAS)

  From start to the end of treatment at 3 weeks, and at follow-up at 6 months.

Study Arms (1)

CIMT in a clinical setting

Those who underwent modified constraint-induced movement therapy in a clinical setting in Sweden during the years 2000-2018.

Other: Constraint-induced movement therapy (CIMT)

Interventions

Constraint-induced movement therapy (CIMT) OTHER

Clinically implemented modified CIMT. Including the three main components; intensive and repetitive task-oriented training of the affected limb, constraint of the non-affected limb and behavioural strategies known as the Transfer Package. In this model the training is supervised by therapist from several professions and some training sessions is performed in group settings with other inpatients and outpatients undergoing primary rehabilitation at the clinic.

CIMT in a clinical setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Jönköping County: lead
• Futurum - Academy for health and care: collaborator

Study Sites (1)

Department of Rehabilitation Medicine, Region Jönköping County

Jönköping, SE-551 85, Sweden

Location

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Kersti Samuelsson, Assoc.Prof.

  Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Physiotherapist, Master of Science

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 4, 2024
• Study Start: August 14, 2000
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)