Clinical trial NCT04013750: Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia
Official title: Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Functions of Stroke Patients With Right/Left Hemisphere Damage: Single Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Patients
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale.

Detailed description: For the rehabilitation of the paretic upper extremity, the use of constraint induced movement therapy and the use of modified constraint induced movement therapy are the most effective treatment strategies. The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage.

A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. 10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale. Wilcoxon Signed Ranks test and Friedman test were used for intragroup comparison of data and Kruskal-Wallis test was used to compare data between groups.

Eligibility criteria: Inclusion Criteria:

* Patients in subacute and chronic period (3 months after stroke)
* Modified Ashworth scale in the hemiplegic arm with 3 or more spasticity
* No pain in the hemiplegic arm
* MMSE 20 and above
* Without major medical problems
* No previous stroke history
* Adequate stability to walk when healthy arm is immobilized
* Active 20 degrees wrist extension and 10 degrees interphalangeal and metacarpophalangeal extension (these movements should be repeated 3 times in 1 minute)

Exclusion Criteria:

* Bilateral stroke or brainstem affected
* Active 20-degree wrist extension and 10-degree interphalangeal and metacarpophalangeal extension
* Global aphasia or cognitive disorders that may affect understanding of test instructions
* Patients with major medical problems that may affect participation
* Existence of neglect

Primary outcomes:
measure: Motor Activity Log
timeFrame: Patients were examined at baseline
measure: Motor Activity Log
timeFrame: Patients were examined 2 weeks after baseline
measure: Motor Activity Log
timeFrame: Patients were examined 3 months after baseline
measure: Fugl-Meyer Motor Assessment Scale
timeFrame: Patients were examined at baseline
measure: Fugl-Meyer Motor Assessment Scale
timeFrame: Patients were examined 2 weeks after baseline
measure: Fugl-Meyer Motor Assessment Scale
timeFrame: Patients were examined 3 months after baseline
measure: Box-Block Test
timeFrame: Patients were examined at baseline
measure: Box-Block Test
timeFrame: Patients were examined 2 weeks after baseline
measure: Box-Block Test
timeFrame: Patients were examined 3 months after baseline
measure: exercise assessment parameters-cubes lined
timeFrame: Patients were examined at baseline
measure: exercise assessment parameters-cubes lined
timeFrame: Patients were examined 2 weeks after baseline
measure: exercise assessment parameters-cubes lined
timeFrame: Patients were examined 3 months after baseline
measure: exercise assessment parameters-card turned
timeFrame: Patients were examined at baseline
measure: exercise assessment parameters-card turned
timeFrame: Patients were examined 2 weeks after baseline
measure: exercise assessment parameters-card turned
timeFrame: Patients were examined 3 months after baseline
measure: exercise assessment parameters-object gripped
timeFrame: Patients were examined at baseline
measure: exercise assessment parameters-object gripped
timeFrame: Patients were examined 2 weeks after baseline
measure: exercise assessment parameters-object gripped
timeFrame: Patients were examined 3 months after baseline
measure: exercise assessment parameters-water
timeFrame: Patients were examined at baseline
measure: exercise assessment parameters-water
timeFrame: Patients were examined 2 weeks after baseline
measure: exercise assessment parameters-water
timeFrame: Patients were examined 3 months after baseline
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: Patients were examined at baseline
measure: Stroke Impact Scale
timeFrame: Patients were examined 2 weeks after baseline
measure: Stroke Impact Scale
timeFrame: Patients were examined 3 months after baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medicine Faculty
state: Physical Medicine And Rehabilitation
Study officials:
affiliation: istanbul university physical medicine and rehabilitation
name: ayşe yalıman, professor
role: STUDY_DIRECTOR
References:
citation: Yadav RK, Sharma R, Borah D, Kothari SY. Efficacy of Modified Constraint Induced Movement Therapy in the Treatment of Hemiparetic Upper Limb in Stroke Patients: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):YC01-YC05. doi: 10.7860/JCDR/2016/23468.8899. Epub 2016 Nov 1.