NCT04873908

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

April 30, 2021

Last Update Submit

October 14, 2021

Conditions

StrokeRehabilitation

Keywords

Modified constraint-induced therapyProprioceptive Trainingconventional rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Modified Ashworth Scale

    Score change after 6 weeks of intervention compared to baseline

  • thumb localizing test

    Score change after 6 weeks of intervention compared to baseline

Study Arms (3)

conventional rehabilitation

OTHER
Other: conventional rehabilitation

Modified constraint-induced therapy

EXPERIMENTAL
Other: modified constraint-induced therapy

Proprioceptive Training

EXPERIMENTAL
Other: Proprioceptive Training

Interventions

modified constraint-induced therapyOTHER

Patients received conventional rehabilitation and modified constraint-induced therapy schedule

Modified constraint-induced therapy
Proprioceptive TrainingOTHER

Patients received conventional rehabilitation and Proprioceptive Training schedule

Proprioceptive Training
conventional rehabilitationOTHER

Patients received conventional rehabilitation schedule

conventional rehabilitation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assit Prof. Nuray Alaca

Study Record Dates

First Submitted

April 30, 2021

First Posted

May 5, 2021

Study Start

May 5, 2021

Primary Completion

July 15, 2021

Study Completion

September 20, 2021

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations

TU(1)