Innovative Physiotherapy in Stroke Rehabilitation

Stroke, Ischemic Clinical Trial

Official title:

Innovative Physiotherapy in Stroke Rehabilitation During the Subacute Stage - a Prospective Randomized Single Blinded Controlled Trial and a Qualitative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069767
• Other study ID #: StrokeCoreDIST
• Status: Completed
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: December 5, 2021

Study information

• Verified date: April 2022
• Source: Nordlandssykehuset HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study has the potential to improve rehabilitation during the subacute phase of a stroke, aiming to reduce the individual's disabilities and risk of falling, enhance health promoting physical activity and independence in ADL.

Description:

The purpose of the RCT is to investigate the effects of an innovative physiotherapy intervention, called I-CoreDIST when applied in comprehensive rehabilitation after discharge from a stroke unit and throughout the rehabilitation chain.The project investigate: 1) effects on postural control and balance in various positions and functional activities. Effects on and level of physical activity, and 2) user's identifications of positive and negative features in content and coordination of physiotherapy integrated in post stroke rehabilitation. Function parameters of balance, gait and levels of physical activity at baseline and at 12 weeks will be compared to those obtained from the standard care group. Semistructured interviews will be conducted to identify patients' perceptions of key positive and negative features of content and coordination of I-CoreDIST and standard care rehabilitation after a stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 5, 2021
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• A stroke diagnosis

• Can sit for 10 seconds without support

• Age 18-85

• Trunk Impairment Scale-Norwegian version (TIS-NV) < 15

• Pre-stroke modified Ranking Scale (mRS) 0-3

Exclusion Criteria:

• Dementia

• Unable to cooperate in physiotherapy

• On-going substance abuse

• Severe co-morbidity preventing rehabilitation, severe neurological diseases such as Parkinson disease, Multiple Sclerosis and brain tumor.

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

Procedure:
• ICoreDIST
The intervention consists of exercises that demand enhancement of dynamic trunk stability and functional movements, combined with the following: Optimised alignment and adaptation to the base of support and often using an unstable reference point for the trunk (therapeutic ball) or the distal body parts. Enhanced somatosensory integration of hands, feet and face, including reduced influence of vision to enhance somatosensory integration. Proximal stability prior to selective task-oriented movement of limbs, head, eyes. Inclusion of dual tasks (motor/motor and motor/cognitive) in exercises and activities such as walking indoors, out-doors and climbing stairs. Specific hands-on interactions or other adaptations to optimise alignment and neuromuscular recruitment. Exercises combining core activation and moderate increase in heart rate: in lying, sitting, standing and walking.
• Standard Care
According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.

Locations

Country	Name	City	State
Norway	Nordlandssykehuset HF	Bodø
Norway	Sykehuset Levanger	Levanger

Sponsors (6)

Lead Sponsor	Collaborator
Nordlandssykehuset HF	Helse Nord, Helse Nord-Trøndelag HF, Nord University, University of Illinois at Chicago, University of the Basque Country (UPV/EHU)

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Normann B, Arntzen EC, Sivertsen M. Comprehensive core stability intervention and coordination of care in acute and subacute stroke rehabilitation-a pilot study. European Journal of Physiotherapy; DOI: 10.1080/21679169.2018.1508497, 2018.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk Impairment Scale Norwegian Version	Validated scale to assess dynamic sitting balance. The test consists of ordinal 6 sub scales summed to measure dynamic sitting balance and trunk coordination.The scale ranges from 0-16 points where higher score indicates better sitting balance	12 weeks
Primary	ActiGraph WgtX-BT	Accelerometer recording levels of physical activity and number of steps	13 weeks
Secondary	Swedish Postural Assessment Scale For Stroke Norwegian Version	PASS is a validated postural assessment scale specifically designed to assess and monitor postural control after stroke. It contains 12 four-level items (0-3 points) of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The scale ranges from 0-36 points, sub-items are summed to calculate a total score. Higher score indicates better postural control.	12 weeks
Secondary	MiniBESTest	Validated scale to measure pro-and reactive balance in standing and walking	12 weeks
Secondary	Bodyfitter seat sensor system	Pressure mat to register distribution of weight during sitting	12 weeks
Secondary	Amti Force Platform	Device to register postural sway in standing	12 weeks
Secondary	10 meter walk test	Validated test to assess walking speed	12 weeks
Secondary	2 minute walk test	Validated test to assess walking distance	12 weeks
Secondary	EQ-5D-3L	Survey to assess self-perceived quality of life. The EQ-5D-3L comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension.; The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement.	12 weeks
Secondary	Stroke Specific Quality of Life Scale	Survey to assess self-perceived quality of life. Stroke-Specific Quality-of-Life (SSQOL) scale is designed to measure multiple effects in poststroke patients. The scale consists of 49 questions grouped into 12 domains. Each domain is assessed on 5-point Gutterman type scales. Provides both summary and domain-specific scores. Domain scores are composed of unweighted averages. Summary scores are composed of an unweighted average of the 12 domain average scores. Scores range from 49-245 and higher scores indicate better functioning.	1 day