Effects of Modified Constraint-Induced on Chronic Stroke Patients

Stroke Clinical Trial

Official title:

Comparison of the Effect of Proprioceptive Training Therapy or Modified Constraint-Induced Movement Therapy on Upper Extremity Physical Functions in Chronic Stroke Patients - A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873908
• Other study ID #: 2020-24/05
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: September 20, 2021

Study information

• Verified date: October 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the present study, it was aimed to compare the proprioception training applied in addition to conventional treatment and Modified Constraint-Induced Movement Therapy treatment in patients with chronic strokes and to investigate the effects on proprioception, spasticity, functional motor skills and daily living activities in the upper extremity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 20, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Post stroke hemiparetic patients of six months
• spasticity = Grade -3 on modified Ashworth scale
• those patients capable of extension of at least 10º each at Metacarpophalangeal (MCP), Proximal Interphalangeal (PIP) and Distal Interphalangeal (DIP) joints and 20º at wrist joint
• a score of 24 or higher on the Modified Mini-Mental State Examination
• no excessive pain in the affected upper limb, as measured by a score of 4 or higher on a 10-point visual analog scale

Exclusion Criteria:

• Patients with history of previous stroke,
• angina,
• uncontrolled hypertension, on medication that could impair neuromuscular performance,
• wrist or finger pathologies, significant visual or hearing impairment,
• balance problems which may compromise safety during sound upper limb constraint,
• unwilling to participate

Related Conditions & MeSH terms

• Rehabilitation
• Stroke

Intervention

Other:
• modified constraint-induced therapy
Patients received conventional rehabilitation and modified constraint-induced therapy schedule
• Proprioceptive Training
Patients received conventional rehabilitation and Proprioceptive Training schedule
• conventional rehabilitation
Patients received conventional rehabilitation schedule

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer assessment test	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based upper extremity function. The maximum available score is 66 and The minimum available score is zero.The higher total score means better motor function in the arm	Score change after 6 weeks of intervention compared to baseline
Primary	Action Research arm test	The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance. The maximum available score from the 19 items was 57. The higher total score means better motor function in the arm	Score change after 6 weeks of intervention compared to baseline
Primary	Motor Activity Log	Daily use of the affected upper extremity was assessed using Motor Activity Log. It is a self-statement questionnaire to determine the frequency and quality of movement in the upper extremity. Score range is 0-5, The higher total score means better motor function in the arm	Score change after 6 weeks of intervention compared to baseline
Secondary	Modified Ashworth Scale	Modified Ashworth Scale was measure muscle spasticity. It is among the most commonly used scales for clinical and research purposes. The resistance against passive movement is evaluated on a scale of 0-4 points.The lower total score means better spasticity in the arm	Score change after 6 weeks of intervention compared to baseline
Secondary	thumb localizing test	A proprioception examination, called the 'thumb localizing test' (TLT), is described as a technique for testing 'limb localization'. With the patient's eyes closed, the examiner positions one of the patient's upper limbs (fixed limb) and asks him to pinch the thumb of that limb with the opposite thumb and index finger (reaching limb).It is evaluated on a 0-3 point scale. The lower the total score, the better the proprioceptive in the arm.	Score change after 6 weeks of intervention compared to baseline